GLYCARE ACNE - glycolic acid gel 
MD Formulation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Glycare Acne Gel

Salicylic Acid 1%

Acne Tratment

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

Clears up acne blemishes and helps prevent new acne blemishes.

For external use only.

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.

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

Label
Unit Carton
GLYCARE ACNE 
glycolic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66078-035-2554 in 1 CASE
11 in 1 CARTON
172 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/07/2001
Labeler - MD Formulation (087008363)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 7/2011
Document Id: 6e906461-55a1-4620-9406-c0f50cf9d221
Set id: ea482e54-e5af-4b57-a75f-e8c1f473f965
Version: 3
Effective Time: 20110705
 
MD Formulation