Otc - Active Ingredient
Active ingredient:
- Salicylic Acid 17%
Dr.johnes Skin Tag Remover Solution
FDA Label NDC 85818-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr.johnes Llc for the product Dr.johnes Skin Tag Remover (NDC 85818-002). 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, otc - purpose, indications & usage, warnings, otc - 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
Otc - Purpose
- Skin Tag, Wart, corn, and callus remover
Indications & Usage
Uses For the removal of common
- warts
- corns
- calluses
Warnings
For external use only
Otc - Do Not Use
Do not use:
- on mucous membranes, or broken skin
- Do not apply to open wounds or infected skin
Otc - When Using
When using this product
Avoid contact with eyes
Otc - Stop Use
Stop use and ask a doctor if
- excessive irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
- Clean and dry the affected area
- Apply a thin layer once or twice daily
- Do not apply to open wounds or infected skin
Other Safety Information
Other information:
- Store at room temperature
- Avoid heat and direct sunlight
Inactive Ingredient
Inactive ingredients:
- Menthol
- Coptis chinensis extract (COPTIS CHINENSIS ROOT)
- Phellodendron extract (PHELLODENDRON CHINENSIS BARK)
- Acorus gramineus extract (ACORUS GRAMINEUS ROOT)
- Ethanol (ALCOHOL)
- Water (WATER)
Otc - Questions
Questions or comments?
Package Label.Principal Display Panel
Available in 7 mL, 8 mL, 9 mL, and 10 mL tubes. All packages look the same externally, with the only variation being fill volume.
Package1 Of 10 mL (Img1 10ml)
Package2 Of 10 mL (Img2 10ml)
* Please review the disclaimer below.
