VICHY LABORATOIRES NORMADERM TRIPLE ACTION 3 IN 1 CLEANSER- salicylic acid cream

Vichy Laboratoires Normaderm by

Drug Labeling and Warnings

Vichy Laboratoires Normaderm 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...0.5%

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

• use twice daily as a cleanser/scrub: massage onto damp face
• as a mask: apply a thin layer to the face and let dry for 5 minutes
• rinse off with water
• in case of contact with eyes, rinse immediately

Keep out of reach of children.

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

Inactive ingredients

water, kaolin, butylene glycol, zea mays (corn) starch, glycerin, decyl glucoside, titanium dioxide, polyethylene, chondrus crispus (carrageenan), PEG-7 glyceryl cocoate, glycolic acid, zinc gluconate, blue 1 lake, sodium hydroxide, sodium chloride, coco-betaine, dipotassium glycyrrhizate, disodium EDTA, chromium oxide greens, xanthan gum, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VICHY LABORATOIRES NORMADERM  TRIPLE ACTION 3 IN 1 CLEANSER
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-332
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)
KAOLIN (UNII: 24H4NWX5CO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO-BETAINE (UNII: 03DH2IZ3FY)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHROMIC OXIDE (UNII: X5Z09SU859)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-332-01	125 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/01/2012

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(49967-332)