QUITACALLOS- salicylic acid cream 
Caribe Natural, 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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ACTIVE INGREDEINT: Salicylic Acid 17% (w/w)

Corn & Callus Remover

Keep this and all drugs out of the reach of children.

QuitaCallos

Removedor de Callos

Corn & Callus Remover

Salicylic Acid 17%

Directions: Wash affected area and dry thoroughly. Brush on corn or callus only, not on healthy skin. Let dry. Repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed). You may also soak corn/callus in warm water for 5 minutes to assist in removal.

Warnings: For external use only. Do not use this product on irritated skin, or on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation. If discomfort persists, see your doctor or a podiatrist. Extremely flammable. Keep away from fire or flame. Cap bottle tightly and store at room temperature away from heat. If product gets into eye, flush with water for 15 minutes. Avoid inhaling vapors.

Inactive Ingredients: flexible collodion, isopropyl alcohol.

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QUITACALLOS 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-712
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PYROXYLIN (UNII: KYR8BR2X6O)  
ETHER (UNII: 0F5N573A2Y)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59561-712-0515 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F05/05/2015
Labeler - Caribe Natural, Inc (624210480)
Establishment
NameAddressID/FEIBusiness Operations
World Perfumes, Inc101312044manufacture(59561-712)

Revised: 5/2015
Document Id: 79501f0c-43b5-4c65-b77b-fc761b31185b
Set id: ec111e88-bd6a-4503-acc4-e0cc26b0d1ce
Version: 1
Effective Time: 20150505
 
Caribe Natural, Inc