MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1%- tolnaftate 1% liquid 
Denison Pharmaceuticals, LLC

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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Maximum Strength Anti Fungal Tolnaftate 1%

Active ingredient

Tolnaftate 1%

Purpose

Anti-fungal

Uses

  • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • For effective relief of itching, burning and cracking.

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

Directions:

  • Clean affected area with soap and warm water and dry thoroughly.
  • Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid over affected area twice daily (morning and night) or as directed by a doctor.
  • The brush applicator allows for easy application on skin around the nail and cuticle areas.
  • Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot pay special attention to spaces between the toes.
  • For athlete's foot and ringworm, use daily for 4 weeks. For toe fungus, apply under nail and around cuticle areas. If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
  • Supervise children in the use of this product.

Other information: Store at room temperature 15°-30°C (59°-86°). Protect from freezing. If freezing occurs warm to room temperature.

Inactive ingredient

Aloe Vera Leaf, Benzoic Acid, Caprylyl Glycol, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Citric Acid, Dimethicone 350, Ethylhexyl Glycerin, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil, Triethyl Citrate

Label

label 1

label 2

MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1% 
tolnaftate 1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTOL (UNII: RV6J6604TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9017-071 in 1 BOX07/11/2019
130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:0295-9017-021 in 1 BOX08/02/2023
215 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
3NDC:0295-9017-051 in 1 BOX08/02/2023
330 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/11/2019
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-9017)

Revised: 8/2023
 
Denison Pharmaceuticals, LLC