Label: KERASAL ATHLETES FOOT POWDER- tolnaftate spray
- NDC Code(s): 16864-110-01
- Packager: Advantice Health, LLC
- 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 May 25, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Extremely Flammable do not use while smoking or near heat or flame.
When using this product avoid contact with the eyes
- Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
- Wash the 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
- 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 condition persists longer, ask a doctor
- To prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
- This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
PRINCIPAL DISPLAY PANEL - 56 g Can Label
For Athlete's Foot
Invisible Powder Spray
5 IN 1™
Most Athlete's Foot
Itching, Burning And Scaling
Improves Skin Appearance
With Essential Oils
Enriched with Natural Tea Tree Oil,
Aloe, Ceramides & Vitamin E
NET WT 2.0 oz (56 g)
INGREDIENTS AND APPEARANCE
KERASAL ATHLETES FOOT POWDER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16864-110 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 ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CERAMIDE NG (UNII: C04977SRJ5) DIMETHICONE (UNII: 92RU3N3Y1O) EUCALYPTUS OIL (UNII: 2R04ONI662) ISOBUTANE (UNII: BXR49TP611) ISODODECANE (UNII: A8289P68Y2) PEPPERMINT OIL (UNII: AV092KU4JH) STARCH, TAPIOCA (UNII: 24SC3U704I) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16864-110-01 57 g in 1 CAN; Type 0: Not a Combination Product 02/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 02/28/2022 Labeler - Advantice Health, LLC (192527062)