Label: ATHLETES FOOT- tolnaftate spray
- 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.
Updated December 21, 2018
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
For external use only.
Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF (49oC).
When using this product
- avoid contact with eyes and face
- use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
Stop use and ask a doctor if
- irritation occurs
- there is no improvement after 4 weeks
DOSAGE & ADMINISTRATION
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night)
- 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 a day
- use daily for 4 weeks; if condition persists longer, consult a doctor
- to prevent athlete's foot, apply once or twice daily (morning and night)
- this product is not effective on the scalp or nails
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-007 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 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) ALCOHOL (UNII: 3K9958V90M) PROPANE (UNII: T75W9911L6) PPG-12-BUTETH-16 (UNII: 58CG7042J1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-007-01 150 g in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/04/2014 Labeler - DOLGENCORP, LLC. (068331990) Establishment Name Address ID/FEI Business Operations Zhejiang Ludao Cosmetics Co., Ltd. 679885595 manufacture(55910-007)