Active Ingredient(S)
Tolnaftate 1% (w/w)
Seebeellar Tolnaftate 1% Antifungal Body Wash Liquid
FDA Label NDC 84558-016
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 Yusong Fine Chemicls Co., Ltd for the product Seebeellar Tolnaftate 1% Antifungal Body Wash (NDC 84558-016). 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(s), purpose, use, warnings, 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
Purpose
Antifungal
Use
1. For the treatment and prevention of common fungal skin
infections (athlete's foot, ringworm, jock itch, and tinea
versicolor) when used as part of your daily shower routine.
2. Temporarily relieves itching, scaling, burning, redness, and
discomfort associated with these fungal conditions, including
tinea versicolor.
2. Cleanses skin thoroughly while delivering antifungal benefits.
Warnings
For external use only
Do Not Use
Do not use on scalp or mucous membranes (eyes, nose, mouth, genital areas). If contact with eyes occurs, rinse
thoroughly with water.
Do not use on children under 2 years of age unless directed by a doctor.
If pregnant or breastfeeding, consult a healthcare professional before use.
Do not use if you areallergic to any ingredient in this product.
Otc - When Using
·Avoid contact with eyes
·If irritation occurs, please stop using
Otc - Stop Use
- Irritation, redness, or rash develops or worsens.
- No improvement in symptoms after 4 weeks for athlete's foot, ringworm, or tinea versicolor, or after 2 weeks for jock itch.
- The infection spreads or becomes severe.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center immediately.
Directions
1. Use daily during shower or bath
2. Wet skin thoroughly, lather into foam, apply to affected areas, and massage gently
3. Leave foam on skin for 1-2 minutes, then rinse thoroughly
4. For best results, use consistently every day
Other Information
Store at room temperature(15°-30°C /59°-86°F)
Protect from excessive heat and direct sunlight
Inactive Ingredients
Aqua, Sodium Lauroyl Sarcosinate,Cocamidopropyl Betaine,
Lauryl Glucoside, Disodium Cocoyl Glutamate,Glycerin, Sodium
Lauroamphoacetate,Trehalose,Panthenol, Hamamelis Virginiana
Water, Phenoxyethanol, Aloe Barbadensis Extract, Sodium
Chloride, Hydrolyzed Sodium Hyaluronate, Hydrolyzed Oats,
Allantoin, Sodium Benzoate, Menthol, Arginine,Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Mentha Arvensis Extract,Citric
Acid, Fragrance, Disodium Edta
Package Label - Principal Display Panel
Undefined (Label)
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