Otc - Active Ingredient
ZINC UNDECYLENATE 20%
UNDECYLENIC ACID 5%
Tea Tree Oil Antifungal Foot Cream
FDA Label NDC 85966-007
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 Saweilan Import & Export Trading Co., Ltd for the product Tea Tree Oil Antifungal Foot Cream (NDC 85966-007). 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
Antifungal
Indications & Usage
Proven effective in the treatment of most athlete's foot (tinea pedis) . Helps prevent most athlete's foot with daily use
For effective relief of itching, burning and cracking.
Warnings
For external use only.
Otc - Do Not Use
Do not use if seal under cap is broken or missing. Close the lid tightly after use.
Do not use this product if you are allergic to any of its ingredients.
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
Ask a doctor before use if you have .Diabetes.
When using this product . Avoid contact with the eyes.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Stop Use
Stop use and ask a doctor if , lrritation occurs There is no improvement within 4 weeks.
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
Test a small area on your skin to check for any potential allergic reaction. . Clean affected area with soap and water anddry thoroughly, · Apply a thin layer over affected area twice daily (morning and night). . Use daily for 4 weeks. if conditionoersists longer, consult a doctor. . For athlete's foot, pay special attention to spaces between the toes, . To preventathlete's foot, apply once or twice daily (morning and/or night). ’ Supervise children in the use of this product, . Thisproduct is not effective on the scalp or nails.
Inactive Ingredient
UREA
WATER
C13-15 ALKANE
MELALEUCA ALTERNIFOLIA LEAF OIL
SQUALANE
GLYCERIN
CetearyAlcohol/CETEARYL ALCOHOL
GLYCEROL STEARATE
PEG-100 STEARATE
PANTHENOL
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
LEPTOSPERMUM SCOPARIUM OIL
CERAMIDE COMPLEX CLR K
PHENOXYETHANOL
ORIGANUM VULGARE HIRTUM LEAF OIL
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
ARGININE
CAPRYLYL GLYCOL
MENTHOL
XANTHAN GUM
DISODIUM EDTA
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Label (Label)
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