MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1%- tolnaftate 1% liquid

Maximum Strength Anti Fungal Tolnaftate 1% by

Drug Labeling and Warnings

Maximum Strength Anti Fungal Tolnaftate 1% by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Tolnaftate 1%

PURPOSE

Purpose

Anti-fungal

INDICATIONS & USAGE

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

Warnings

For external use only.

DO NOT USE

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

Stop use and ask a doctor if

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1% 
tolnaftate 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZOIC ACID (UNII: 8SKN0B0MIM)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9017-07	1 in 1 BOX	07/11/2019
1		30 mL in 1 BOTTLE, WITH APPLICATOR; 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	07/11/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9017)