VICHY LABORATOIRES NORMADERM BEAUTIFYING ANTI ACNE CARE 24 H HYDRATING ACNE TREATMENT- salicylic acid lotion

Vichy Laboratoires Normaderm Beautifying Anti Acne Care 24 H Hydrating Acne Treatment by

Drug Labeling and Warnings

Vichy Laboratoires Normaderm Beautifying Anti Acne Care 24 H Hydrating Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, COSMETIQUE ACTIVE PRODUCTION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

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, dimethicone, glycerin, hydrogenated polyisobutene, alcohol denat., butylene glycol, glyceryl stearate, ammonium polyacryloyldimethyl taurate, isopropyl lauroyl sarcosinate, octyldodecanol, PEG-100 stearate, stearyl alcohol, dimethicone/vinyl dimethicone crosspolymer blue 1, silica silylate, sodium hydroxide, silica, sodium polyacrylate, perlite, phenylethyl resorcinol, poloxamer 338, disodium EDTA, capryloyl salicylic acid, capryloyl glycine, xanthan gum, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, fragrance

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 BEAUTIFYING ANTI ACNE CARE 24 H HYDRATING ACNE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-411
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PERLITE (UNII: 0SG101ZGK9)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
POLOXAMER 338 (UNII: F75JV2T505)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-411-01	1 in 1 CARTON	01/01/2016
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(49967-411)