Otc - Active Ingredient
Salicylic Acid 1.5% w/w
Totclear Genital Wart Remover Ointment
FDA Label NDC 87725-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Good Bridge Llc for the product Totclear Genital Wart Remover (NDC 87725-001). 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
Wart Remover
Indications & Usage
For the removal of warts, especially genital warts.
Warnings
For external use only.
Otc - Do Not Use
Do not use:
- On irritated, infected, or reddened skin
- On the face or mucous membranes
- Not recommended for those with diabetes or poor circulation
Otc - When Using
When using this product:
- Keep away from fire and flame.
- Ask a doctor before use if pregnant or breastfeeding.
- Children should use under adult supervision.
- Avoid contact with eyes. If in eyes, flush with water for 15 minutes.
- Avoid inhaling vapors.
Otc - Stop Use
Stop use and consult a doctor if discomfort persists.
Otc - Keep Out Of Reach Of Children
Children should use under adult supervision.
Dosage & Administration
Direction:
- For better results, soak the area in warm water for 5 minutes.
- Clean and dry the affected area.
- Apply a thin layer of ointment using a cotton swab, covering the wart.
- Allow the ointment to absorb fully.
- Repeat 1-2 times a day for around 4 weeks.
- Cover with a bandage if needed.
Other Safety Information
Other Information: Store the cream in a dry, cool, and shady place.
Otc - Questions
Questions or comments? Contact us at: [email protected]
Inactive Ingredient
Inactive Ingredients:
- Water
- Polyethylene Glycol
- Glycerin
- Borneol
- Methylparaben
- Chlorhexidine
Package Label.Principal Display Panel
* Please review the disclaimer below.
