ACNE TREATMENT CLEAR GEL - MAXIMUM STRENGTH- salicylic acid gel

Acne Treatment Clear Gel - Maximum Strength by

Drug Labeling and Warnings

Acne Treatment Clear Gel - Maximum Strength by is a Otc medication manufactured, distributed, or labeled by McCure Health Solutions Inc., Jiangsu Dedi Medical Device Co., Ltd... Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

for the treatment and prevention of acne pimples

Warnings

for external use only.

do not use

if you have sensitive skin or are sensitive to Salicylic Acid.

When using this product

avoid contact with eyes, lips and mouth.

• if using with other topical acne medications, at the same time or immediately following use of this product, increased dryness of the skin may occur. If this occurs, only one medication should be used unless otherwise directed by a doctor. Skin irritation may occur characterized by redness, burning, itching, peeling or possible swelling. Mild irriation may be reduced by using this product less frequently or lower concentration. Stop  use and ask a doctor if skin irritation becomes severe.

KEEP OUT OF REACH OF CHILDREN.

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

Directions

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times day. Use to prevent new pimples from forming.

Other information

• store at 15 - 30 C (59 - 86 F)
• close cap tightly after use
• do not use if seal on tube is punctured or missing
• keep away from heat

Inactive ingredients

DMDM HYDANTOIN, GLYCERIN, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL, WATER

Product Label

INGREDIENTS AND APPEARANCE

ACNE TREATMENT CLEAR GEL - MAXIMUM STRENGTH 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-010
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 g

Inactive Ingredients
Ingredient Name	Strength
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52486-010-28	1 in 1 CARTON	03/27/2015
1		28 g 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	03/27/2015

Labeler - McCure Health Solutions Inc. (053034873)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Dedi Medical Device Co., Ltd..		544458936	manufacture(52486-010)