PHARMA CLEAR MOISTURIZER- salicylic acid lotion

PHARMA CLEAR MOISTURIZER by

Drug Labeling and Warnings

PHARMA CLEAR MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by PHARMAGEL INTERNATIONAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Salicylic Acid 1.0%

PURPOSE

Acne Medication

Uses

Use for treatment of acne. Decreases bacteria on the skin.

WARNINGS

Warning: For external use only

When using this product:

avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the 

   skin. If this occurs, only one medication should be used unless directed by a doctor.

Limit use to the face and neck.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Apply to clean skin. Cover the entire affected area with a thin layer twice daily. If dryness or peeling occurs, reduce application.

INACTIVE INGREDIENTS:

WATER (AQUA), DIMETHICONE PEG-8 MEADOWMEADOWFOAMATE, GLYCERETH-26, AMINOMETHYL PROPANOL, CARBOMER, BENZYL ALCOHOL, BETAINE, BISABOLOL, DISODIUM EDTA-COPPER, SODIUM PCA, TRICLOSAN, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, PANTHENOL, PEG-40 HYDROGENATED CASTOR OIL, TOCOPHERYL ACETATE, SORBITOL, SERINE, GLYCINE, GLUTAMIC ACID, ALANINE, LYSINE, ARGININE, SODIUM HYALURONATE, THREONINE, PROLINE, RETINYL PALMITATE, ZEA MAYS (CORN) OIL, CHOLECALCIFEROL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, PHENOXYETHANOL, CAPRYLYL GLYCOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHARMA CLEAR MOISTURIZER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
GLYCERETH-26 (UNII: NNE56F2N14)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETAINE (UNII: 3SCV180C9W)
LEVOMENOL (UNII: 24WE03BX2T)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRICLOSAN (UNII: 4NM5039Y5X)
TEA TREE OIL (UNII: VIF565UC2G)
PANTHENOL (UNII: WV9CM0O67Z)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITOL (UNII: 506T60A25R)
SERINE (UNII: 452VLY9402)
GLYCINE (UNII: TE7660XO1C)
GLUTAMIC ACID (UNII: 3KX376GY7L)
ALANINE (UNII: OF5P57N2ZX)
LYSINE (UNII: K3Z4F929H6)
ARGININE (UNII: 94ZLA3W45F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
THREONINE (UNII: 2ZD004190S)
PROLINE (UNII: 9DLQ4CIU6V)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-103-11	175 mL in 1 TUBE; Type 0: Not a Combination Product	06/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/18/2015

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Registrant - PHARMAGEL INTERNATIONAL INC (603215182)