BENGAMA ANTIFUNGAL- tolnaftate solution 
Genuine Drugs

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.

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Bengama Antifungal Solution

Active ingredient (in each gram)

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use

on children under 2 years of age except under the advice and supervision of a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

dehydrated ethyl alcohol, butylated hydroxytoluene, polyethylene glycol

Other information

Package label

Bengama antifungal

carton

BENGAMA ANTIFUNGAL 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69666-831
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69666-831-041 in 1 BOX04/20/2015
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/20/2015
Labeler - Genuine Drugs (079610378)

Revised: 2/2023
Document Id: f4ee990c-0636-122a-e053-2995a90a948e
Set id: 1432381d-4f2b-4e76-e054-00144ff8d46c
Version: 4
Effective Time: 20230217
 
Genuine Drugs