Label: HONGO KILLER- tolnaftate aerosol, powder
- NDC Code(s): 58593-285-04
- Packager: Efficient Laboratories Inc
- 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 1, 2021
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
For external use only
Flammable:Contents under pressure. Do not puncture or incinerate or store at a temperature above 120 degrees F. Use only as directed. intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or while smoking.
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- clean the affected area and dry thoroughly
- shake can well before use: Hold can about 6 inches from the area to be treated.
- apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
- supervise children in the use of this product
Athlete's Foot and Ringworm - use daily for 4 weeks
Jock Itch - use daily for 2 weeks
- to prevent most athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
For athlete's foot:
- pay special attention to the spaces between the toes
- wear well-fitting, ventilated shoes, and change shoes and socks at least once a day
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
tolnaftate aerosol, powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-285 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 0.1 g in 10 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) KAOLIN (UNII: 24H4NWX5CO) PPG-12-BUTETH-16 (UNII: 58CG7042J1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-285-04 130 g in 1 CANISTER; Type 0: Not a Combination Product 03/01/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/01/2002 Labeler - Efficient Laboratories Inc (969044932) Establishment Name Address ID/FEI Business Operations American Spraytech, LLC 137135237 manufacture(58593-285)