14% AZELAIC ACID ACNE- azelaic acid cream 
Guangdong Bisutang Biotechnology Co., Ltd.

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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

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: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.

Azelaic Acid

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

Acne treatment

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

Label image

14% AZELAIC ACID ACNE 
azelaic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84753-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84753-056-0130 g in 1 BOTTLE; Type 0: Not a Combination Product03/12/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00603/12/2026
Labeler - Guangdong Bisutang Biotechnology Co., Ltd. (447075429)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Bisutang Biotechnology Co., Ltd.447075429manufacture(84753-056)

Revised: 3/2026
Document Id: 4ccaa734-83bf-611b-e063-6294a90ab3bf
Set id: 4ccaa734-83be-611b-e063-6294a90ab3bf
Version: 1
Effective Time: 20260311
 
Guangdong Bisutang Biotechnology Co., Ltd.