Active Ingredient(S)
Salicylic Acid 12%
Wart Remover
FDA Label NDC 81799-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ehy Holdings Llc for the product Wart Remover (NDC 81799-004). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, 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
Use
use :
for the removal of common and plantar warts
the common war is easy ily recognized by the rough macauli flowerlike " appearance of the surface
the plantar wart is recognized by its location only on the bottom ofthe foot . its tenderness and the interru option of the foot pró nt pattern
Warnings
Warnings
For externall use
Do Not Use
Do not use
on irritated skin or on any area that is infected or reddened
Do not use on moles skin tags , birthmarks , warts with hair growing from them , genital warts , or warts on the face or mucous membranes
Otc - When Using
Ask a doctor before you use
if you have diabetes or poor blood circulation
Stop use and ask a doctor
if discomfort persists
Keep out of reach of children
If product gets into eyes , flush with water for 15 minutes
IF swallowed , get medical help or contact a Poison Control Center right away
Otc - Stop Use
Stop use and ask a doctor
if discomfort persists
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If product gets into eyes , flush with water for 15 minutes
IF swallowed , get medical help or contact a Poison Control Center right away
Directions
Directions :
Wash the affected area and dry it
Apply this product with a cotton swab to the wart
Repeat this procedure twice daily as needed ( until wart is removed ) for up to 12 weeks
Other Information
Other information
Store at room temperature and out of direct sunlight
skin discoloration may occur during or affter use
Inactive Ingredients
Water
BRUCEA JAVANICA FRUIT
Coptis Chinensis Root Extract
Phellodendron Amurense Bark Extract
LONICERA JAPONICA TOP
Triclosan
Borneol
Package Label - Principal Display Panel
81799-004-01
81799-004-01 (81799 004 01)
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