NDC | 70242-106-01 |
Set ID | 65927394-abb7-406f-ac5f-5fd85e80aada |
Category | HUMAN OTC DRUG LABEL |
Packager | Dannso Corp./d.b.a. Essential Products |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333C |
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- wash the affected area and dry thoroughtly
- apply a thin layer over the affected area twice daily morning and night
- supervice 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)
-
INGREDIENTS AND APPEARANCE
FUNGISOLVE TOLNAFTATE ANTIFUNGAL
tolnaftate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70242-106 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 BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) DMDM HYDANTOIN (UNII: BYR0546TOW) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) METHYL SALICYLATE (UNII: LAV5U5022Y) PEPPERMINT OIL (UNII: AV092KU4JH) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70242-106-01 30 mL in 1 TUBE, WITH APPLICATOR; 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(70242-106) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 MANUFACTURE(70242-106)