Label: TM-TOLNAFTATE LR- tolnaftate liquid
- NDC Code(s): 83035-1262-4
- Packager: Singular Dreamer Ltd.dba True Marker
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 21, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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Uses
- for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
- for the prevention of most Athlete's foot with daily use eliminates fungus on fingers, toes and around the nails.
- eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.
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Warnings
• For external use only
• Do Not Use– On children under 2 years of age
• When using this product, do not get into eyes
• Stop use and ask a doctor- for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
- for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor
- for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
- for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor
- KEEP OUT OF REACH OF CHILDREN
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Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles and skin around the nails 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 well-fitting,ventilated shoes, and change shoes and socks at least once
- daily for athlete's foot and ringworm, use daily for 4 weeks
- if condition persists longer, consult a doctor.
- Other information
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Inactive ingredients
a-Bisabalol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Curcuma Longa (Turmeric) Extract, Dimethyl Isosorbide, Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethyl Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate
60, Sodium Hydroxide, Thymus Vulgaris (Thyme) Extract, Zingiber Officinalis (Ginger) Extract. - Product label
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INGREDIENTS AND APPEARANCE
TM-TOLNAFTATE LR
tolnaftate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83035-1262 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength BISABOLOL OXIDE A (UNII: 16AE65F94Y) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) TURMERIC (UNII: 856YO1Z64F) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) ISOHEXADECANE (UNII: 918X1OUF1E) ISOPROPYL ALCOHOL (UNII: ND2M416302) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 60 (UNII: CAL22UVI4M) SODIUM HYDROXIDE (UNII: 55X04QC32I) THYME (UNII: CW657OBU4N) GINGER (UNII: C5529G5JPQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83035-1262-4 1 in 1 CARTON 06/26/2023 1 45 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/01/2023 Labeler - Singular Dreamer Ltd.dba True Marker (129504103) Registrant - Singular Dreamer Ltd.dba True Marker (129504103)
