ACNE- salicylic acid cream 
GREENBRIER INTERNATIONAL INC

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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DRUG FACTS

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

for the treatment of acne

Warnings

For external use only.

Do not use if you have very sensitive skin or are sensitive to Salicylic Acid

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day.

Other information

store at 20 to 25 C (66 to 77 F)

Inactive ingredients

carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water

Acne Cream LabelEnter section text here

ACNE 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1307
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O) 2 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1307-11 in 1 BOX
143 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/2013
Labeler - GREENBRIER INTERNATIONAL INC (610322518)
Registrant - HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED (547695235)
Establishment
NameAddressID/FEIBusiness Operations
HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED547695235manufacture(33992-1307)

Revised: 7/2014
Document Id: 8c93f61f-6598-4554-ba46-6ef7c8421a14
Set id: 11e15eef-240b-40cf-b644-4f23b606a640
Version: 3
Effective Time: 20140721
 
GREENBRIER INTERNATIONAL INC