Label: DR. SCHOLLS INSTANT COOL ATHLETES FOOT TREATMENT WITH MENTHOL- tolnaftate spray
- NDC Code(s): 73469-0691-1
- Packager: Scholl's Wellness Company
- 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 March 22, 2022
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- Drug Facts
- Active ingredient
For external use only
Flammable: Do not use while smoking or near heat or flame
When using this product
- avoid contact with the eyes
- use only as directed. Interntional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
- contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm)
- wash affected area and dry thoroughly
- shake can well and spray a thin layer on the affected area twice daily (morning and night)
- pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- supervise children in the use of this product
- for treatment of athlete's foot and ringworm, use daily for 4 weeks.
- to prevent athlete's foot, apply once a twice daily (morning and/or night)
- Other information
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
DR. SCHOLLS INSTANT COOL ATHLETES FOOT TREATMENT WITH MENTHOL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73469-0691 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DIMETHYL ETHER (UNII: AM13FS69BX) MENTHOL (UNII: L7T10EIP3A) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) PPG-12-BUTETH-16 (UNII: 58CG7042J1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73469-0691-1 150 g in 1 CAN; Type 0: Not a Combination Product 03/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/10/2022 Labeler - Scholl's Wellness Company (117174744)