Otc - Active Ingredient
SALICYLIC ACID 17%
LACTICUM ACIDUM 1%
Wart Removal
FDA Label NDC 83575-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhenshi Liuxiang Yuntian Network Technology Co., Ltd. for the product Wart Removal (NDC 83575-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, uses, warnings, otc - do not use, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Wart remover
Uses
- For removal of common and plantar warts.
- Common warts can be easily recognized by the rough cauliflflower-like appearance of the surface
- Plantar warts can be recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern
Warnings
Ask a doctor before use if you have
- If you have diabetes or poor blood circulation
- On irritated skin or any area that is inflflated or reddened
- On moles,birthmarks,warts with hair growing from them, genital warts, or warts on the face or mucous membranes
Otc - Do Not Use
Cautions
- For external use only
- Flammable, keep away from fire and flames
- Pregnant women, lactating women, people with allergies, children under 3 years old, and people with damaged skin should avoid using it
When Using This Product
- If product gets in eyes,flush with water for 15 minutes
- Cap bottle tightly when not in use and store at room temperature away from heat
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed by mistake, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
If swallowed by mistake, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- a wash affected area , may soak wart in warmwater for 5 minuteso
- dry thoroughly, apply one drop at a time withapplicator to sufficiently cover each wart
- let dry , self-adhesive cover-up discs may beused to conceal wart
- Repeat procedure once or twice daily as needed (until wart is removed) for up to 12 weeks
Other Information
- Product storage period is 3 years
- Store at temperature (59-86℉ / 15-30℃).
- It needs to be placed in a cool place and awayfrom direct sunlight
Inactive Ingredient
GLYCERIN, POLYOXYL 40 HYDROGENATED CASTOR OIL, POLYVINYL ALCOHOL (108000 MW), WATER
Package Label.Principal Display Panel
83575-002-01 (83575 002 01)
83575-002-02 (83575 002 02)
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