14% AZELAIC ACID ACNE- azelaic acid cream

14% Azelaic Acid Acne by

Drug Labeling and Warnings

14% Azelaic Acid Acne by is a Otc medication manufactured, distributed, or labeled by Guangdong Bisutang Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

30g,

Cleanse the skin thoroughly before applying.Apply a thin layer to affected area and gently massage until fully absorbed.Use once or
twice daily,or as directed by a doctor

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

Azelaic Acid

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children,If swallowed,get medical help rightaway

PURPOSE

Acne treatment

INDICATIONS & USAGE

Uses: Helps treat acne and reduce the appearance of blemishes.Helps improve uneven-looking skin tone caused by acne.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

14% AZELAIC ACID ACNE 
azelaic acid cream

Product 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)