Label: QUITACALLOS- salicylic acid cream
Contains inactivated NDC Code(s)
NDC Code(s): 59561-712-05
- Packager: Caribe Natural, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 5, 2015
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- ACTIVE INGREDIENT
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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.
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INGREDIENTS AND APPEARANCE
salicylic acid cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59561-712 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:59561-712-05 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 - Caribe Natural, Inc (624210480) Establishment Name Address ID/FEI Business Operations World Perfumes, Inc 101312044 manufacture(59561-712)