The following Structured Product Label (SPL) was submitted to the FDA by Twincraft Inc. for the product Antifungal 1% Clotrimazole Cream (NDC 64412-2010). 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 inactive ingredients, active ingredient, purpose, warnings, directions, uses, artwork, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Inactive ingredients: Allantoin, Avena Sativa (Oat) Kemel Flour, Butyrospermum Parkii (Shea) Butter,
Calophyllum Tacamahaca Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cellulose Gum, Cetearyl Alcohol,
Citric Acid, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate. Melia Azadirachta Seed Oil, Microcrystalline
Cellulose, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Gluconate, Sodium Polyacrylate Starch,
Urea, Water, Xanthan Gum
Active ingredients: Clotrimazole 1.0%
Antifungal
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes.
Stop use and ask a doctor if irritation occurrs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions Wash and diy affected area thoroughly. Apply a thin layer over affected area twice daily
(moming and night). Supervise children in the use of this product. For athlete’s foot: pay special attention
to the spaces between the toes. Wear well-fitting, 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, ask a doctor. This product is not effective on the scalp or nails
Proven clinically effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris). For effective relief of itching, burning, and cracking skin.
* Please review the disclaimer below.
