MAXIMUM STRENGTH ANTI FUNGAL LIQUID- tolnaftate 1% liquid

Maximum Strength Anti Fungal Liquid by

Drug Labeling and Warnings

Maximum Strength Anti Fungal Liquid 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)
• Helps prevent most athlete's foot with daily use
• 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.
• 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 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, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ANTI FUNGAL LIQUID 
tolnaftate 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9024
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 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9024-16	1 in 1 BOX	11/20/2019
1		3 mL in 1 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	11/20/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9024)