# CITRIC ACID MONOHYDRATE

URL: https://app.greenveil.ai/ingredients/ingredient_dtxsid_dtxsid7074668
Categories: beauty, cleaning, food, industrial, pharma
Functions: pH regulating agent, Processing aids not otherwise specified
Identifier: DTXSID7074668

> CITRIC ACID MONOHYDRATE is used as ph regulating agent / processing aids not otherwise specified. EPA CPDat observed this chemical in 60 composition records across product categories including Laboratory supplies, Food and drug, Raw materials. Assessed from 96 sources.

## Safety assessment

- Chemical concern: not yet assessed
- Rationale: EPA CPDat observed this chemical in 60 composition records across product categories including Laboratory supplies, Food and drug, Raw materials.

## Regulatory status

- US: commercial use observed — EPA CPDat observed this chemical in 60 composition records across product categories including Laboratory supplies, Food and drug, Raw materials. EPA CPDat classifies this chemical for functional uses including pH regulating agent, Processing aids not otherwise specified.
- US: inactive ingredient database — Route: AURICULAR (OTIC); Dosage form: SOLUTION; Potency: 0.2 %w/v
- US: inactive ingredient database — Route: AURICULAR (OTIC); Dosage form: SOLUTION/ DROPS; Potency: 0.04 %w/w
- US: inactive ingredient database — Route: BUCCAL; Dosage form: SOLUTION; Potency: NA
- US: inactive ingredient database — Route: EPIDURAL; Dosage form: INJECTION; Potency: 0.02 %w/v
- US: inactive ingredient database — Route: INFILTRATION; Dosage form: INJECTION; Potency: 0.02 %w/v
- US: inactive ingredient database — Route: INTRA-ARTICULAR; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: INTRA-ARTICULAR; Dosage form: INJECTION, SOLUTION; Potency: ADJ PH
- US: inactive ingredient database — Route: INTRABURSAL; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: INTRACARDIAC; Dosage form: INJECTION; Potency: 1.05 %w/v
- US: inactive ingredient database — Route: INTRALESIONAL; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION; Maximum daily exposure: 28 mg
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, POWDER, FOR SOLUTION; Potency: NA
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, SOLUTION; Maximum daily exposure: 26 mg
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE; Maximum daily exposure: 38 mg
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: SOLUTION; Potency: 0.05 %w/v
- US: inactive ingredient database — Route: INTRAOCULAR; Dosage form: INJECTION, SOLUTION, CONCENTRATE; Potency: 0.24 mg/5ml
- US: inactive ingredient database — Route: INTRAOCULAR; Dosage form: SOLUTION; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: INTRAPLEURAL; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: INTRASYNOVIAL; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: INTRATHECAL; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION; Potency: 2068 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, POWDER, FOR SOLUTION; Maximum daily exposure: 608 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION; Maximum daily exposure: 385 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, SOLUTION; Maximum daily exposure: 396 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: LIQUID; Potency: 0.2 %w/v
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: SOLUTION; Maximum daily exposure: 10 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: SOLUTION, CONCENTRATE; Potency: NA
- US: inactive ingredient database — Route: IONTOPHORESIS; Dosage form: SOLUTION; Potency: 0.02 %w/v
- US: inactive ingredient database — Route: IONTOPHORESIS; Dosage form: SYSTEM; Potency: 0.2 mg
- US: inactive ingredient database — Route: IRRIGATION; Dosage form: INJECTION, SOLUTION, CONCENTRATE; Potency: 0.03 %w/v
- US: inactive ingredient database — Route: NASAL; Dosage form: SOLUTION; Potency: 2.8 mg/1ml
- US: inactive ingredient database — Route: NASAL; Dosage form: SPRAY; Maximum daily exposure: 9 mg
- US: inactive ingredient database — Route: NASAL; Dosage form: SPRAY, METERED; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SOLUTION; Potency: 0.03 %w/v
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SOLUTION/ DROPS; Potency: 0.05 %w/v
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SUSPENSION; Potency: ADJ PH
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 238 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 101 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CONCENTRATE; Potency: 5.3 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: DROPS; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: ELIXIR; Potency: 100 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: GRANULE, FOR SUSPENSION; Maximum daily exposure: 113 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: LIQUID; Maximum daily exposure: 114 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER; Maximum daily exposure: 840 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SOLUTION; Maximum daily exposure: 315 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 840 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 446 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Maximum daily exposure: 269 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION, EXTENDED RELEASE; Potency: 140.8 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION/ DROPS; Maximum daily exposure: 19 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SYRUP; Potency: 722 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Potency: 914 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, CHEWABLE; Potency: 7 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, COATED; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EFFERVESCENT; Potency: 460 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 45 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Maximum daily exposure: 42 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING; Maximum daily exposure: 83 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TROCHE; Potency: 12 mg
- US: inactive ingredient database — Route: PERIDURAL; Dosage form: INJECTION; Potency: NA
- US: inactive ingredient database — Route: PERINEURAL; Dosage form: INJECTION; Potency: 0.02 %w/v
- US: inactive ingredient database — Route: RECTAL; Dosage form: AEROSOL, FOAM; Maximum daily exposure: 7 mg
- US: inactive ingredient database — Route: RESPIRATORY (INHALATION); Dosage form: INHALANT; Potency: NA
- US: inactive ingredient database — Route: RESPIRATORY (INHALATION); Dosage form: LIQUID; Potency: 0.13 %w/w
- US: inactive ingredient database — Route: RESPIRATORY (INHALATION); Dosage form: SOLUTION; Maximum daily exposure: 8 mg
- US: inactive ingredient database — Route: RESPIRATORY (INHALATION); Dosage form: SUSPENSION; Potency: 0.03 %w/v
- US: inactive ingredient database — Route: SOFT TISSUE; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: SUBCUTANEOUS; Dosage form: INJECTION; Maximum daily exposure: 28 mg
- US: inactive ingredient database — Route: SUBCUTANEOUS; Dosage form: INJECTION, SOLUTION; Maximum daily exposure: 26 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: FILM; Maximum daily exposure: 10 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Maximum daily exposure: 24 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: AEROSOL, FOAM; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: EMULSION; Potency: 0.11 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: 0.85 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: OINTMENT; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: POWDER, FOR SOLUTION; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SHAMPOO; Maximum daily exposure: 17 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SHAMPOO, SUSPENSION; Potency: 0.25 %w/v
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOAP; Potency: 0.5 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOLUTION; Maximum daily exposure: 17 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOLUTION/ DROPS; Potency: 0.01 %w/v
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SWAB; Potency: 0.05 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SYSTEM; Potency: 0.2 mg
- US: inactive ingredient database — Route: TRANSDERMAL; Dosage form: FILM, EXTENDED RELEASE; Potency: 1.38 mg
- US: inactive ingredient database — Route: VAGINAL; Dosage form: CREAM; Potency: 0.49 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: DOUCHE; Potency: 0.07 %w/w
- US: marketed drug occurrence — FDA NDC lists this ingredient in 1 active drug products and 1 total products.
- US: marketed drug occurrence — FDA NDC lists this ingredient in 50 active drug products and 51 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.

_Assessed by Greenveil._