Label: LOTRIMIN DAILY PREVENTION DEO- tolnaftate aerosol, powder
- NDC Code(s): 11523-0010-1, 11523-0010-2
- Packager: Bayer HealthCare 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 July 6, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For external use only
Flammable: Do not use near heat, flame, or while smoking
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
to prevent athlete’s foot, wash the feet and dry thoroughly.
shake can well and spray a thin layer of the product on the feet once or twice daily (morning and/or 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.
- Other information
- INACTIVE INGREDIENT
- Display can 160 grams
INGREDIENTS AND APPEARANCE
LOTRIMIN DAILY PREVENTION DEO
tolnaftate aerosol, powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0010 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) TALC (UNII: 7SEV7J4R1U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PPG-12-BUTETH-16 (UNII: 58CG7042J1) ISOBUTANE (UNII: BXR49TP611) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-0010-1 160 g in 1 CAN; Type 0: Not a Combination Product 02/14/2020 2 NDC:11523-0010-2 133 g in 1 CAN; Type 0: Not a Combination Product 02/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/14/2020 Labeler - Bayer HealthCare LLC. (112117283)