Label: TOLNAFATE- tolnaftate jock itch powder spray - talc free aerosol, spray
- NDC Code(s): 68016-653-46
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 25, 2023
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- Active ingredient
- Purpose
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WARNINGS
For external use only.
Flammable:
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF
- Directions
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
TOLNAFATE
tolnaftate jock itch powder spray - talc free aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-653 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1.3 g in 130 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) KAOLIN (UNII: 24H4NWX5CO) PPG-12-BUTETH-16 (UNII: 58CG7042J1) ALCOHOL (UNII: 3K9958V90M) ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-653-46 130 g in 1 CAN; Type 0: Not a Combination Product 10/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/31/2017 Labeler - Chain Drug Consortium, LLC (101668460)