Label: BLISTEX ODOR-EATERS POWDER- tolnaftate spray
- NDC Code(s): 10157-4645-1, 10157-4645-2
- Packager: Blistex 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 December 17, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in liquid)
Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- Shake container well before use.
- To prevent athlete's foot, wash the feet and dry thoroughly. Holding can 8" from the skin, 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.
- Wash hands after use.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 113 g Can Label
INGREDIENTS AND APPEARANCE
BLISTEX ODOR-EATERS POWDER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-4645 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 ISOBUTANE (UNII: BXR49TP611) SODIUM BICARBONATE (UNII: 8MDF5V39QO) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-4645-1 113 g in 1 CAN; Type 0: Not a Combination Product 12/09/2013 2 NDC:10157-4645-2 151 g in 1 CAN; Type 0: Not a Combination Product 11/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 12/09/2013 Labeler - Blistex Inc (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc 005126354 MANUFACTURE(10157-4645)