Label: GENITAL WART REMOVER OINTMENT.- genital wart remover cream cream
- NDC Code(s): 83299-009-01
- Packager: Consilii LLC
- 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 June 29, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- When Using
- Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
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Directions
wash the affected area
may soak the wart in warm water for 5 minutes
dry area thoroughly
using the applicator(cotton swab), apply a layer of ointment to sufficiently cover each wart
allow it to fully absorb and cover it with a bandage as needed.
repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks - Inactive ingredients
- Questions
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GENITAL WART REMOVER OINTMENT.
genital wart remover cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83299-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROACETIC ACID (UNII: 5GD84Y125G) (CHLOROACETIC ACID - UNII:5GD84Y125G) CHLOROACETIC ACID 1 g in 100 g SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 g Inactive Ingredients Ingredient Name Strength BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y) HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T) SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) BORNEOL (UNII: M89NIB437X) CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS) LONICERA JAPONICA WHOLE (UNII: UV4X7MQQ43) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALCOHOL (UNII: 3K9958V90M) XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C) CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX) CABBAGE (UNII: GW0W1Y9I97) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83299-009-01 20 g in 1 BOTTLE; Type 0: Not a Combination Product 06/29/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 06/29/2023 Labeler - Consilii LLC (118891890) Establishment Name Address ID/FEI Business Operations Consilii LLC 118891890 label(83299-009) , manufacture(83299-009)