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.

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Fungi Nail Toe and Foot Ointment


Active IngredientPurpose
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

carton

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

label

FUNGI NAIL TOE AND FOOT 
tolnaftate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-8604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-8604-561 in 1 CARTON08/12/2019
120 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0295-8604-571 in 1 CARTON08/12/201911/06/2019
226.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/12/2019
Labeler - Denison Pharmaceurticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmecuticals001207208manufacture(0295-8604)

Revised: 11/2022
 
Denison Pharmaceurticals, LLC