FUNGI NAIL TOE AND FOOT- tolnaftate ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
Denison Pharmaceurticals, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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. Do not use on children under 2 years of age unless directed by a doctor. Stop use and ask a doctor if ■ Irritation occurs. ■ There is no improvement within 4 weeks.
Authorization status:
OTC monograph final
Authorization number:
0295-8604-56, 0295-8604-57

FUNGI NAIL TOE AND FOOT- tolnaftate ointment

Denison Pharmaceurticals, 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.

----------

Fungi Nail Toe and Foot Ointment

Active Ingredient

Purpose

Tolnaftate 1%

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 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.

Other information

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

warm to room temperature.

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

FUNGI NAIL TOE AND FOOT

tolnaftate ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 29 5-8 6 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TO LNAFTATE (UNII: 0 6 KB6 29 TKV) (TOLNAFTATE - UNII:0 6 KB6 29 TKV)

TOLNAFTATE

1 g in 10 0 g

Inactive Ingredients

Denison Pharmaceurticals, LLC

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CARBO MER HO MO PO LYMER TYPE A ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: F6 8 VH75CJC)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

DIMETHICO NE 3 50 (UNII: 2Y53S6 ATLU)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PO LO XAMER 18 8 (UNII: LQA7B6 G8 JG)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

EUCALYPTO L (UNII: RV6 J6 6 0 4TK)

LAVENDER O IL (UNII: ZBP1YXW0 H8 )

O LIVE O IL (UNII: 6 UYK2W1W1E)

TEA TREE O IL (UNII: VIF56 5UC2G)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 29 5-8 6 0 4-56

1 in 1 CARTON

0 8 /12/20 19

1

20 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 29 5-8 6 0 4-57

1 in 1 CARTON

0 8 /12/20 19

11/0 6 /20 19

2

26 .6 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

0 8 /12/20 19

Labeler -

Denison Pharmaceurticals, LLC (001207208)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Deniso n Pharmecuticals

0 0 120 720 8

ma nufa c ture (0 29 5-8 6 0 4)

Revised: 11/2019

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