Otc - Active Ingredient
Salicylic Acid 5%
For the removal of common warts.
Skin Tag Remover Patches Patch
FDA Label NDC 85593-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Skin Tag Remover Patches (NDC 85593-006). 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, otc - keep out of reach of children, otc - purpose, warnings, dosage & administration, indications & usage, inactive ingredient, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
KEEP OUT OF CHILDREN
Otc - Purpose
Fast HealingTransparentWaterproofNon-DryingDrug-Free
Warnings
Warnings.The labeling of the product contains the following warnings underthe heading “Warnings”
(1)For products containing any ingredient identified in S MO28.10.(i)For external use only.(ii) Do not use this product on irritated skin, on any area that isinfected or reddened, if you are a diabetic, or if you have poorblood circulation.
(iii) lf discomfort persists, see your doctor.(iv) Do not use on moles, birthmarks, warts with hair growing fromthem, genital warts, or warts on the face or mucous membranes.
(2) For any product formulated in a flammable vehicle.(i)The labeling should contain an appropriate flammability signalword, e.g.“extremely flammable",“flammable".“combustible”consistent with 16 CFR 1500.3(b)(10).(ii) Keep away from fire or flame.
Dosage & Administration
(1)For the removal of common warts. The common wart is easily
recognized by the rough 'cauliflower-like’ appearance of the surface.
Indications & Usage
For the removal of plantar warts on the bottom of the foot. The
plantar wart is recognized by its location only on the bottom of the
foot, its tenderness, and the interruption of the footprint pattern.
Inactive Ingredient
Salicylic acidTea tree oilCepress leaf extractSaffron
GlycerinArgan oilVitamin E
Otc - Do Not Use
Do not use this product on irritated skin, on any area that is
infected or reddened, if you are a diabetic, or if you have poor
blood circulation.
Package Label.Principal Display Panel
Labeling (85593 006 01)
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