VICHY LABORATOIRES NORMADERM BHA EXFOLIATING ACNE TREATMENT- salicylic acid lotion

Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment by

Drug Labeling and Warnings

Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment by is a Otc medication manufactured, distributed, or labeled by COSMETIQUE ACTIVE PRODUCTION, Interspray. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 1%

Purpose

Acne treatment

Uses

• for the treatment of acne
• clears acne blemishes and allows skin to heal
• helps prevent new acne blemishes

Warnings

For external use only

Flammable until dry.

Keep away from flames and heat.

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• cleanse the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because too much drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

water, alcohol denat., hydroxyethylpiperazine ethane sulfonic acid, glycolic acid, glycerin, propanediol, sodium hydroxide, PEG/PPG/polybutylene glycol-8/5/3 glycerin, sodium polyacrylate, adenosine, ammonium polyacryloyldimethyl taurate, ascorbyl glucoside, vitreoscilla ferment, trisodium ethylenediamine disuccinate, xanthan gum, panthenol, menthol

Questions or comments?

Call toll free 1-877-37-VICHY (84249)

Monday – Friday (9 a.m. to 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VICHY LABORATOIRES NORMADERM BHA EXFOLIATING ACNE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69625-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)
GLYCOLIC ACID (UNII: 0WT12SX38S)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ADENOSINE (UNII: K72T3FS567)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
VITREOSCILLA LYSATE (UNII: 68DV8T89Y2)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69625-231-01	1 in 1 CARTON	12/12/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69625-231-02	1 in 1 CARTON	12/12/2022	06/01/2023
2		3 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69625-231-03	1 in 1 CARTON	12/12/2022
3		5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/12/2022

Labeler - COSMETIQUE ACTIVE PRODUCTION (282658798)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(69625-231)

Establishment
Name	Address	ID/FEI	Business Operations
Interspray		364829903	pack(69625-231)