Label: FUNGISOLVE TOLNAFTATE ANTIFUNGAL- tolnaftate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 70242-104-01 - Packager: Dannso Corp./d.b.a. Essential Products
- 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 April 30, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Flammable
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- wash the affected area and dry thoroughtly
- spray a thin layer over the affected area twice daily morning and night
- supervis 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 a day.
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- if the condiotion persists longer, ask a doctor
- this product is not effective on scalp or nails
- Other Information
- Inactive Ingredients
- Questions or Comments?
- Distributed by:
- FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) SPRAY
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INGREDIENTS AND APPEARANCE
FUNGISOLVE TOLNAFTATE ANTIFUNGAL
tolnaftate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70242-104 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SODIUM BISULFITE (UNII: TZX5469Z6I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70242-104-01 44 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/16/2011 Labeler - Dannso Corp./d.b.a. Essential Products (059741071) Registrant - Dannso Corp./d.b.a. Essential Products (059741071) Establishment Name Address ID/FEI Business Operations Dannso Corp./d.b.a. Essential Products 059741071 LABEL(70242-104) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 MANUFACTURE(70242-104)
