Active Ingredient
salicylic acid 17%
Elsophie Wart Cream
FDA Label NDC 83818-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Elsophie Wart Cream (NDC 83818-030). 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, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Wart Remover
Use
■ for the removal of common warts
■ for the removal of plantar warts
Warnings
For external use only
Do Not Use
■ on irritated skin or on any area that is infected or reddened
■ if you are a diabetic
■ if you have poor blood circulation
■ on moles, birthmarks, warts with hair growing from them,genital warts, or warts on the face or mucous membranes
When Using
■ avoid contact with eyes
■ avoid applying to healthy skin surrounding the wart
■ skin irritation may occur
Stop Use
■ discomfort persists
■ irritation becomes severe
■ wart does not improve within 12 weeks
Ask Doctor
■ discomfort persists
■ irritation becomes severe
■ wart does not improve within 12 weeks
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ wash affected area
■ may soak wart in warm water for 5 minutes
■ dry area thoroughly
■ apply one drop at a time with applicator to sufficiently cover each wart
■ let dry
■ repeat this procedure once or twice daily as needed
(until wart is removed) for up to 12 weeks
Other Information
store at room temperature 20°–25°C (68°–77°F)
keep container tightly closed
Inactive Ingredients
Purified Water,Carbomer,Triethanolamine,Propylene Glycol,Alcohol
Questions
TEL:+1 858 905 0218
www.elsophi.com
Principal Display Panel
1 (Pack)
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