VICHY LABORATOIRES NORMADERM PHYTOACTION ACNE CONTROL MOISTURIZER- salicylic acid gel

Vichy Laboratoires Normaderm Phytoaction Acne Control Moisturizer by

Drug Labeling and Warnings

Vichy Laboratoires Normaderm Phytoaction Acne Control Moisturizer by is a Otc medication manufactured, distributed, or labeled by COSMETIQUE ACTIVE PRODUCTION, Socoplan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid...2%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

When using this product

kin 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

clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
because excessive 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, glycerin, isononyl isononanoate, butylene glycol, kaolin, zinc sulfate, bifida ferment lysate, sodium hydroxide, sodium polyacrylate, sodium hyaluronate, sodium benzoate, phenoxyethanol, ascorbyl glucoside, hydrolyzed algin, trisodium ethylenediamine disuccinate, biosaccharide gum-1, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance

Questions or comments?

Call toll free 1-877-378-4245

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VICHY LABORATOIRES NORMADERM PHYTOACTION ACNE CONTROL MOISTURIZER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69625-605
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
KAOLIN (UNII: 24H4NWX5CO)
ZINC SULFATE (UNII: 89DS0H96TB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69625-605-01	1 in 1 CARTON	09/01/2020
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69625-605-02	1 in 1 CARTON	09/01/2020	06/01/2026
2		3 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69625-605-03	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	09/01/2020	06/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/01/2020

Labeler - COSMETIQUE ACTIVE PRODUCTION (282658798)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(69625-605) , pack(69625-605)