10% AZELAIC ACID ACNE CREAM cream

10% azelaic acid acne cream by

Drug Labeling and Warnings

10% azelaic acid acne cream by is a Otc medication manufactured, distributed, or labeled by Guangzhou Ariel Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

WHEN USING

Discontinve use if any irritation or adverse reaction occurs.

STOP USE

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

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

INGREDIENTS AND APPEARANCE

10% AZELAIC ACID ACNE CREAM 
10% azelaic acid acne cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84148-009
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASIATICOSIDE (UNII: PKO39VY215) (ASIATICOSIDE - UNII:PKO39VY215)	ASIATICOSIDE	0.015 g  in 100 g
MADECASSOSIDE (UNII: CQ2F5O6YIY) (MADECASSOSIDE - UNII:CQ2F5O6YIY)	MADECASSOSIDE	0.055 g  in 100 g
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) (CENTELLA ASIATICA TRITERPENOIDS - UNII:4YS74Q4G4J)	CENTELLA ASIATICA TRITERPENOIDS	0.03 g  in 100 g
LAVANDIN OIL (UNII: 9RES347CKG) (LAVANDIN OIL - UNII:9RES347CKG)	LAVANDIN OIL	0.03 g  in 100 g
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)	AZELAIC ACID	10 g  in 100 g
O-CYMEN-5-OL (UNII: H41B6Q1I9L) (O-CYMEN-5-OL - UNII:H41B6Q1I9L)	O-CYMEN-5-OL	0.09 g  in 100 g
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) (CAPRYLOYL GLYCINE - UNII:8TY5YO42NJ)	CAPRYLOYL GLYCINE	0.15 g  in 100 g
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I) (HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID - UNII:RWW266YE9I)	HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID	0.5 g  in 100 g
TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y) (TARAXACUM OFFICINALE LEAF - UNII:0022LFJ74Y)	TARAXACUM OFFICINALE LEAF	0.01 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84148-009-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product	09/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/29/2024

Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ariel Biotech Co., Ltd.		402818771	manufacture(84148-009)