FUNGI NAIL TOE AND FOOT- tolnaftate ointment

Fungi Nail Toe and Foot by

Drug Labeling and Warnings

Fungi Nail Toe and Foot by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceurticals, LLC, Denison Pharmecuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredient: Purpose
• Tolnaftate 1%: 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

For external use only.

DO NOT USE

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

WHEN USING

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 areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail ® Anti-Fungal Ointment over affected area twice daily (morning and night) or as directed by a doctor. ■ 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 once or twice daily (morning and/or night). ■ For toe fungus, apply under nail and around 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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Inactive ingredients
Aloe Vera Leaf, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Dimethicone 350, Eucalyptol, Lavender Oil, Glyceryl Monostearate, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide,  Tea Tree Oil

PRINCIPAL DISPLAY PANEL

NEW Improved Formula



MAXIMUM STRENGTH



FUNGI-NAIL ®

ANTI-FUNGAL

OINTMENT



CLINICALLY PROVEN TO

CURE AND PREVENT

FUNGAL INFECTIONS



TRIPLE ACTION FORMULA

✓ Kills Fungus

✓ Stops Itching & Burning

✓ Restores Skin Health



CLINICALLY PROVEN INGREDIENT



0.7 FL. OZ. (20 g)



Convenient and Easy to Apply



Deep Penetrating Medicine that Stays in Place



Not actual size.



Patent pending.



#1 Pharmacist Recommended



FUNGI-NAIL ® ANTI-FUNGAL OINTMENT infused with 5 natural oils including tea tree, eucalyptol, aloe, olive and lavender



For best results treat around all toenails and in between toes.



Not for Nail or scalp fungus.



Cures most athlete's foot.



For more information about Fungi-Nail ® and money back guarantee, visit us at funginail.com



Kramer Laboratories, Inc.

Coral Gables, FL 33134

kramerlabs.com

funginail.com

1-800-824-4894



K1118

MAXIMUM STRENGTH



FUNGI-NAIL ®

ANTI-FUNGAL

OINTMENT



KILLS FUNGUS RESTORES SKIN



NET WT 0.7 FL. OZ. (20 G)



Distributed By:

KRAMER LABORATORIES



Kramer Laboratories, Coral Gables, FL 33134 U.S.A.



kramerlabs.com

fungi-nail.com

1-800-824-4894



K0918

INGREDIENTS AND APPEARANCE

FUNGI NAIL TOE AND FOOT 
tolnaftate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-8604
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLOXAMER 188 (UNII: LQA7B6G8JG)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EUCALYPTOL (UNII: RV6J6604TK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)
TEA TREE OIL (UNII: VIF565UC2G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-8604-56	1 in 1 CARTON	08/12/2019
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0295-8604-57	1 in 1 CARTON	08/12/2019	11/06/2019
2		26.6 g in 1 TUBE; 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	08/12/2019

Labeler - Denison Pharmaceurticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmecuticals		001207208	manufacture(0295-8604)