Active Ingredients
Tolnaftate 1%
Bio-scriptives Extreme Af
FDA Label NDC 60608-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biochemics, Inc. for the product Bio-scriptives Extreme Af (NDC 60608-013). 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 ingredients, purpose, uses, warnings, stop use and ask a doctor if, directions, inactive ingredients, reference, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
■ Proven clinically effective in the treatment of athlete's foot.■ Relieves itching and burning feet.
Warnings
■ Do not use on children under 2 years of age.■ Do not use for diaper rash.■ For external use only.■ Avoid contact with eyes.
Stop Use And Ask A Doctor If
- irritation occurs or if there is no improvement within 4 weeks.
Directions
■ Wash the feet and dry thoroughly.
■ Apply a thin layer of product to the feet once or twice daily (morning and/or night).
■ Supervise children in the use of this product.
■ Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
■ Do not use if safety seal is broken.
■ Apply a thin layer of product to the feet once or twice daily (morning and/or night).
■ Supervise children in the use of this product.
■ Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
■ Do not use if safety seal is broken.
Inactive Ingredients
Purified Water, Glyceryl Stearate SE, Stearyl Alcohol, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Olive Oil, Menthol, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, L-Arginine hydroxide, PEG-40 Hdrogenated Castor Oil, Eucalyptus Globulus, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Althaea Officinalis Extract, Echinacea Angustifolia Extract, Allantoin, Tagetes Erecta Extract, Sodium Chloride, Ascophyllum Nodosum Extract, Xanthan Gum, Azadirachta Indica (Neem) Seed Oil, Methylisothiazolinone
Reference
Distributed by BioChemics dba Bio-Scriptives
99 Rosewood Dr. #260 - Danvers, MA 01923
978-750-0790
Keep Out Of Reach Of Children
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