Glycare Acne

Dosage form: gel
Ingredients: SALICYLIC ACID 1g in 100g
Labeler: MD Formulation
NDC Code: 66078-035

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.

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.

GLYCARE ACNE 
glycolic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCOLIC ACID 
HYPROMELLOSE 2208 (15000 MPA.S) 
Packaging
#Item CodePackage Description
1NDC:66078-035-2554 CARTON (CARTON) in 1 CASE
11 TUBE (TUBE) 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/FEIOperations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 07/2011
 
MD Formulation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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