Label: HOMEHEALTH ANTIFUNGAL- tolnaftate lotion
- NDC Code(s): 76020-100-04
- Packager: Home Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- clean the 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 physician; - supervise children in the use of this product; - for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. - for jock itch, use daily for 2 weeks. - for athlete's foot and ringworm, use daily for 4 weeks. - if condition persists longer, consult a doctor. - this product is not effective on the scalp or nails.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients: Almond oil, aloe vera gel, calendula oil, castor oil, cetyl alcohol, citricidal (grapefruit seed extract), cocoa butter, diazolidinyl urea, lanolin oil, lavender oil, methylparaben, myrrh tincture, propylene glycol, propylparaben, rosemary oil, stearic acid, tea tree oil, thyme oil, triethanolamine, water.
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DESCRIPTION
Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm. The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula. You can count on Home Health to deliver the natural heath products your family deserves. No Mineral Oil, No petroleum, No Artificial Colors, No Artificial Fragrance. Carefully Manufactured for HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health B11812 03B
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HOMEHEALTH ANTIFUNGAL
tolnaftate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76020-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CASTOR OIL (UNII: D5340Y2I9G) CETYL ALCOHOL (UNII: 936JST6JCN) GRAPEFRUIT (UNII: O82C39RR8C) COCOA BUTTER (UNII: 512OYT1CRR) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) LANOLIN (UNII: 7EV65EAW6H) LAVENDER OIL (UNII: ZBP1YXW0H8) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) ROSEMARY OIL (UNII: 8LGU7VM393) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) THYME OIL (UNII: 2UK410MY6B) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76020-100-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 02/14/2011 Labeler - Home Health (052609675) Establishment Name Address ID/FEI Business Operations Pure Source, LLC 080354456 manufacture(76020-100)