PHARMA CLEAR SPOT TREATMENT- salicylic acid liquid

PHARMA CLEAR SPOT TREATMENT by

Drug Labeling and Warnings

PHARMA CLEAR SPOT TREATMENT 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 2.0%

PURPOSE

Acne Medication

Uses

Use for treatment of acne and to decrease bacteria on the skin.

WARNINGS

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 sparingly to blemishes after cleansing. Allow to penetrate and dry before applying other preparations. For best results,

use twice daily.

INACTIVE INGREDIENTS:

WATER (AQUA), ALCOHOL DENAT, DIMETHICONE PEG-8 MEADOWFOAMATE, AMINOMETHYL PROPANOL, PVM/MA DECADIENE CROSSPOLYMER, TRICLOSAN, SALIX NIGRA (WILLOW) BARK EXTRACT, DISODIUM EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHARMA CLEAR SPOT TREATMENT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-104-51	1 in 1 BOX	06/15/2016
1	NDC: 67879-104-11	15 mL in 1 TUBE; 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	06/15/2016

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Registrant - PHARMAGEL INTERNATIONAL INC (603215182)