Label: VERRUGUIN- salicylic acid gel
- 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.
Updated May 6, 2015
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
WARNING: For external use only. Do not use; in or near eyes or mucous membranes, on irritated skin, if prone to allergic reaction to any ingredient in this product, on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes, on any area that is infected or reddened, on large areas of the body, on wounds or damaged skin, if you are diabetic, or if you have poor blood circulation. Ask a doctor or pharmacist before use if you are; taking any other medication, or Drinking alcohol. Stop use and ask a doctor if; irritation occurs, condition worsens or does not improve or discomfort persist. If pregnant or breast-feeding. Ask a health professional before use.
Keep the bottle tightly closed
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
salicylic acid gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10095-008 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:10095-008-01 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 part358B 05/05/2015 Labeler - World Perfumes, Inc (101312044) Establishment Name Address ID/FEI Business Operations World Perfumes, Inc 101312044 manufacture(10095-008)