MAXIMUM STRENGTH ANTI FUNGAL LIQUID- 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% Pen

Active ingredient

Tolnaftate 1%

Purpose

Anti-fungal

Uses

  • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • 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.
  • To prevent athlete's foot apply under nail and cuticle area. 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, Dimethicone 350, DMDM Hydantoin, Ededtate Disodium Dihydrate, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Mineral Oil, Olive Oil, PEG 100 Stearate, Phenoxyethanol, Propylene Glycol, Water, Sodium Hydroxide, Tea Tree Oil, Titanium Dioxide, Xanthan Gum

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MAXIMUM STRENGTH ANTI FUNGAL LIQUID 
tolnaftate 1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
EUCALYPTOL (UNII: RV6J6604TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9024-161 in 1 BOX11/20/2019
13 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/20/2019
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-9024)

Revised: 11/2019
 
Denison Pharmaceuticals, LLC