Label: SMARTSENSE MAXIMUM STRENGTH ATHLETES FOOT RELIEF ANTIFUNGAL- tolnaftate spray
- NDC Code(s): 23667-815-01
- Packager: Formulated Solutions, 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 January 23, 2017
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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 intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
- contents under pressure. Do not punture or incinerate. Do not store at temperature above 120°F (49°C).
- 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 toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily
- use daily for 4 weeks; if condition persist longer, ask a doctor
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
- Other information
- Inactive Ingredients
- Questions or comments?
- Package Labeling:
INGREDIENTS AND APPEARANCE
SMARTSENSE MAXIMUM STRENGTH ATHLETES FOOT RELIEF ANTIFUNGAL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23667-815 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 ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23667-815-01 150 g in 1 CAN; Type 0: Not a Combination Product 01/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/23/2017 Labeler - Formulated Solutions, LLC (143266687) Establishment Name Address ID/FEI Business Operations Formulated Solutions, LLC 143266687 manufacture(23667-815)