Label: BENGAMA - TOLNAFTATE- tolnaftate aerosol, spray
- 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 October 17, 2018
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- Drug Facts
- Active ingredient
- INDICATIONS & USAGE
CONTENTS UNDER PRESSURE. Do not expose to heat or open flame, or store at temperatures above 120°F (50°C). Do not spray near naked flame or incandescent material. Do not spray toward face. If eye contact occurs, rinse eyes well with water. If irritation persists, contact a physician. Do not intentionally inhale vapor or spray mist. Avoid contamination of food. Store in a cool dry space. Protect from direct sunlight. Dispose of container properly. Do not puncture or incinerate even when empty.
USE ONLY AS DIRECTED: Intentional misuse by deliberately concentrating and inhaling the contents can be harmful fatal. Help stop inhalant abuse. for more information, visit www.inhalant.org
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
BENGAMA - TOLNAFTATE
tolnaftate aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69666-833 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 PROPANE (UNII: T75W9911L6) ISOBUTANE (UNII: BXR49TP611) ALCOHOL (UNII: 3K9958V90M) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69666-833-04 1 in 1 BOX 11/01/2018 1 128 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/01/2018 Labeler - Genuine Drugs (079610378)