GLYCARE ACNE- glycolic acid gel

Glycare Acne by

Drug Labeling and Warnings

Glycare Acne by is a Otc medication manufactured, distributed, or labeled by MD Formulation, Harmony Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 1%

PURPOSE

Acne Tratment

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Clears up acne blemishes and helps prevent new acne blemishes.

WARNINGS

For external use only.

DOSAGE & ADMINISTRATION

Directions Cleanse skin thoroughly before applying medication.Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

 Water (aqua), sd alcohol 40-b, glycolic acid, ammonium glycolate, hydroxypropyl melhylcellulose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLYCARE ACNE 
glycolic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66078-035
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66078-035-25	54 in 1 CASE
1		1 in 1 CARTON
1		72 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/07/2001

Labeler - MD Formulation (087008363)

Registrant - Harmony Labs, Inc. (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Harmony Labs, Inc.		105803274	manufacture, label, pack, relabel, repack