VICHY LABORATOIRES NORMADERM PHYTOACTION DEEP CLEANSING- salicylic acid gel

Vichy Laboratoires Normaderm Phytoaction Deep Cleansing by

Drug Labeling and Warnings

Vichy Laboratoires Normaderm Phytoaction Deep Cleansing 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...0.5%

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

• use twice daily
• wet face, then work product into a lather
• massage onto face avoiding the eyes
• rinse well

Inactive ingredients

water, coco-betaine, propanediol, PEG-120 methyl glyucose dioleate, sodium chloride, sodium cocoyl glycinate, dipropylene glycol, zinc gluconate, bifida ferment lysate, sodium hydroxide, sodium benzoate, phenoxyethanol, copper gluconate, caprylyl glycol, tetrasodium glutamate diacetate, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VICHY LABORATOIRES NORMADERM PHYTOACTION DEEP CLEANSING 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69625-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-BETAINE (UNII: 03DH2IZ3FY)
PROPANEDIOL (UNII: 5965N8W85T)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COPPER GLUCONATE (UNII: RV823G6G67)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69625-306-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020
2	NDC: 69625-306-02	7 mL in 1 PACKET; Type 0: Not a Combination Product	04/29/2020
3	NDC: 69625-306-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020	08/18/2020
4	NDC: 69625-306-04	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020	08/18/2020
5	NDC: 69625-306-05	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2022
6	NDC: 69625-306-06	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/18/2020	06/01/2023
7	NDC: 69625-306-07	15 mL in 1 TUBE; Type 0: Not a Combination Product	08/18/2020	06/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/15/2020

Labeler - COSMETIQUE ACTIVE PRODUCTION (282658798)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(69625-306) , pack(69625-306)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(69625-306)