Otc - Active Ingredient
Tolnaftate 1%
Tolnaftate 1% Antifungal Soaps Soap
FDA Label NDC 85158-002
9 label sections · Submitted to the FDA by Shenzhen Shangmei Tiantianbaodan E-commerce Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shangmei Tiantianbaodan E-commerce Co., Ltd for the product Tolnaftate 1% Antifungal Soaps (NDC 85158-002). 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 - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
Helps relieve and preventitching, burning,cracking, and scaling associated with fungal infections such as athlete's foot, jock itch,ringworm, and other skin irritations.
Warnings
For externaluse only.
Otc - Do Not Use
Do not use on children under two years of age unless directed by a doctor.
Contains 1% Tolnaftate. Do not use if allergic to any ingredients
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed,call poison controlorseekmedicalhelp.
Dosage & Administration
1.Wet soap and skin with warm water, then lather well.
2.Apply lather to body, hands or feet and massage gently.
3.Rinse thoroughly with cleanwater and pat dry.
4.Use daily for best results. Store in a dry soap bag.
Inactive Ingredient
Cocos Nucifera (Coconut) Oil, Glycerin,Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Sorbitol,Melaleuca Alternifolia (Tea Tree) Leaf Oil,Charcoal Powder, Stearic Acid, Sodium Hyaluronate, Propylene Glycol, EucalyptusGlobulus Leaf Oil, Mentha Haplocalyx (Mint) Oil, Aqua, Centella Asiatica Extract,
Hamamelis Virginiana (Witch Hazel) Extract
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Label (Label)
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