Label: 14% AZELAIC ACID ACNE- azelaic acid cream
- NDC Code(s): 84753-056-01
- Packager: Guangdong Bisutang Biotechnology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 11, 2026
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- Official Label (Printer Friendly)
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INACTIVE INGREDIENT
WATER
GLYCERIN
PROPYLENE GLYCOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
DIMETHICONE
HYDROGENATED POLYDECENE
POTASSIUM CETYL PHOSPHATE
POLYACRYLATE CROSSPOLYMER-6
METHYLPROPANEDIOL
HYDROXYACETOPHENONE
POLYACRYLAMIDE
ALLANTOIN
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
C13-14 ISOPARAFFIN
ISOHEXADECANE
XANTHAN GUM
DISODIUM EDTA
SODIUM HYALURONATE
CAPRYLHYDROXAMIC ACID
POLYSORBATE 80
LAURETH-7
DIPOTASSIUM PHOSPHATE
SORBITAN OLEATE
GLYCERYL CAPRYLATE - DOSAGE & ADMINISTRATION
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WARNINGS
Warnings:For external use only
Avoid contact with eyes and mucous membranes.Mild irritation,redness.or dryness may occur.Stop use and ask a doctor if severe irritation occurs or if symptoms worsen.Do not use on broken or irritated skin or if allergic to any ingredient.lf pregnant or breast-feeding,ask a health professional before use.Keep out of reach of children.If swallowed,get medical help right away. - ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
14% AZELAIC ACID ACNE
azelaic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84753-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID 14 g in 100 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) SODIUM HYALURONATE (UNII: YSE9PPT4TH) WATER (UNII: 059QF0KO0R) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) LAURETH-7 (UNII: Z95S6G8201) HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529) DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPROPANEDIOL (UNII: N8F53B3R4R) XANTHAN GUM (UNII: TTV12P4NEE) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) ISOHEXADECANE (UNII: 918X1OUF1E) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN OLEATE (UNII: 06XEA2VD56) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84753-056-01 30 g in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 03/12/2026 Labeler - Guangdong Bisutang Biotechnology Co., Ltd. (447075429) Establishment Name Address ID/FEI Business Operations Guangdong Bisutang Biotechnology Co., Ltd. 447075429 manufacture(84753-056)
