QUITACALLOS- salicylic acid cream

QuitaCallos by

Drug Labeling and Warnings

QuitaCallos by is a Otc medication manufactured, distributed, or labeled by World Perfumes, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDEINT: Salicylic Acid 17% (w/w)

PURPOSE

Corn & Callus Remover

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

QuitaCallos

Removedor de Callos

Corn & Callus Remover

Salicylic Acid 17%

DOSAGE & ADMINISTRATION

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

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 INGREDIENT

Inactive Ingredients: flexible collodion, isopropyl alcohol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUITACALLOS 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10095-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PYROXYLIN (UNII: KYR8BR2X6O)
ETHER (UNII: 0F5N573A2Y)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10095-006-01	15 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358F	05/05/2015

Labeler - World Perfumes, Inc (101312044)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfumes, Inc		101312044	manufacture(10095-006)