10% AZELAIC ACID ACNE CREAM- 10% azelaic acid acne cream cream 
Guangzhou Ariel Biotech Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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84148-009

Active Ingredient(s)

AZELAIC ACID 10.00000%

HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID 0.50000%

CAPRYLOYL GLYCINE 0.15000%

o-CYMEN-5-OL 0.09000%

MADECASSOSIDE 0.05500%

CENTELLA ASIATICA EXTRACT 0.03000%

LAVANDULA HYBRIDA OIL 0.03000%

ASIATICOSIDE 0.01500%

SAURURUS CHINENSIS LEAF/ROOT EXTRACT 0.01000%

TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT 0.01000%

STEPHANIA TETRANDRA EXTRACT 0.00160%

Purpose

Acne treatment

①Treatments for acne.
②Reduces acne and blemishes.
③Evens skin tone & fades spots.
④Balances oil & prevents breakouts.

Use

Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use
sunscreen during the day.

Warnings

WARNINGS:For external use only. avoid the eye area. Avoid direct sunlight during use.
Discontinue use immediately if rritation occurs. Store in a cool, dry place.

Do not use

Stop using immediately if there is any stimulation

Discontinve use if any irritation or adverse reaction occurs.

For external use only, avoid the eye area. Avoid direct sunlight during use. Discontinue use immediately if rritation occurs. Store in a cool, dry place.

Keep out of reach of children.

Directions

Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use sunscreen during the day.

Other information

No Data

Inactive ingredients

WATER, AZEL AIC ACID, BUTYLENE GLYCOL, METHYLPROPANEDIOL, DIMETHICONE, CETEARYL GLUCOSIDE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, POLYACRYLATE-6, SQUAL ANE, CETYL ALCOHOL, HYDROXYPROPYL CYCLODEXTRIN, 1,2-HEXANEDIOL, 4-HYDROXYACETOPHENONE, HYDROXYETHYLPIPERAZINEETHANE SULFONIC ACID, STEARYL ALCOHOL, ALLANTOIN, CYCLODEXTRIN, CAPRYLOYL GLYCINE, XANTHAN GUM, O-CYMEN-5-OL, MADECASSOSIDE, CENTELLA ASIATICA EXTRACT, LAVANDULA ANGUSTIFOLIA OL, CENTELLA ASIATICA, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, TARAXACUM OFFICINALE LEAF EXTRACT, STEPHANIA TETRANDRAE EXTRACT

Package Label - Principal Display Panel

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10% AZELAIC ACID ACNE CREAM 
10% azelaic acid acne cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84148-009
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASIATICOSIDE (UNII: PKO39VY215) (ASIATICOSIDE - UNII:PKO39VY215) ASIATICOSIDE0.015 g  in 100 g
MADECASSOSIDE (UNII: CQ2F5O6YIY) (MADECASSOSIDE - UNII:CQ2F5O6YIY) MADECASSOSIDE0.055 g  in 100 g
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) (CENTELLA ASIATICA TRITERPENOIDS - UNII:4YS74Q4G4J) CENTELLA ASIATICA TRITERPENOIDS0.03 g  in 100 g
LAVANDIN OIL (UNII: 9RES347CKG) (LAVANDIN OIL - UNII:9RES347CKG) LAVANDIN OIL0.03 g  in 100 g
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID10 g  in 100 g
O-CYMEN-5-OL (UNII: H41B6Q1I9L) (O-CYMEN-5-OL - UNII:H41B6Q1I9L) O-CYMEN-5-OL0.09 g  in 100 g
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) (CAPRYLOYL GLYCINE - UNII:8TY5YO42NJ) CAPRYLOYL GLYCINE0.15 g  in 100 g
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I) (HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID - UNII:RWW266YE9I) HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID0.5 g  in 100 g
TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y) (TARAXACUM OFFICINALE LEAF - UNII:0022LFJ74Y) TARAXACUM OFFICINALE LEAF0.01 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
ALLANTOIN (UNII: 344S277G0Z)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84148-009-0130 g in 1 BOTTLE; Type 0: Not a Combination Product09/29/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/29/2024
Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Ariel Biotech Co., Ltd.402818771manufacture(84148-009)

Revised: 9/2024
Document Id: 233edaed-d60d-ec69-e063-6394a90a2f4f
Set id: 233ed88c-7e76-f8ad-e063-6394a90aa53e
Version: 1
Effective Time: 20240929
 
Guangzhou Ariel Biotech Co., Ltd.