Active Ingredients
TOLNAFTATE 1%
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Aimu Biological Technology Co., Ltd for the product Vxgxo Antifungal With Tea Tree Oil (NDC 83566-620). 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, when using this product, stop use and ask a doctor if, do not use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
TOLNAFTATE 1%
Anti-fungal
1.For effective treatment of most athlete's foot (tinea pedis), ringworm (tineacorporis)and jock itch (tinea cruris).
2.For effective relief of itching, burning, and cracking skin.
3.For the prevention of most athlete's foot (tinea pedis) with daily use.
For external use only
Avoid contact with the eyes.If contact occurs, rinse thoroughly with water.
Use only as directed.
For the treatment of athlete's foot and ringworm:if irritation occurs or if there is no improvement within 4 weeks,discontinue use and consult a doctor.
For the treatment of jock itch:if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
On broken, irritated, or severely damaged skin.Do not use on children under 2 years of age unless directed by a doctor.Do not use for diaper rash.
If swallowed, get medical help or contact a Poison Control Center right away.
Wash he affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product.
For athlete's foot: pay special attention to spaces between the toes; wear wellfitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
STEARIC ACID, MYRISTIC ACID, AQUA, SUCROSE,LAURIC ACID, COCOYL GLUTAMIC ACID, SODIUM HYDROXIDE, SODIUM CITRATE, LONICERA JAPONIC (HONEYSUCKLE) EXTRACT, PROPYLENE GLYCOL,SODIUM LAURYL SULFATE, COCOS NUCIFERA (COCONUT) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL,SULFUR SPRING EXTRACT, SORBITOL, GLYCERIN, ARTEMISIA ARGYI EXTRACT
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