Label: FOOT ODOR CONTROL POWDER- tolnaftate aerosol, spray
- NDC Code(s): 79481-0622-1
- Packager: Meijer Distribution 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 August 28, 2023
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- Active ingredient
For external use only.
Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store above 120°F. Intentional misuse by deliberately concentrating and inhaling the contents cans be harmful or fatal.
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doct
- 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
- use daily for 4 weeks
- if conditions persists, consult a doctor
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
FOOT ODOR CONTROL POWDER
tolnaftate aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0622 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 g Inactive Ingredients Ingredient Name Strength DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISOBUTANE (UNII: BXR49TP611) ALCOHOL (UNII: 3K9958V90M) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0622-1 113 g in 1 CAN; Type 0: Not a Combination Product 08/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/28/2023 Labeler - Meijer Distribution Inc (006959555)