FUNGI NAIL TOE AND FOOT MS- zinc undecylenate undecylenic acid ointment 
Kramer Laboratories

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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Drug Facts


Active IngredientPurpose
Zinc Undecylenate 20%Anti-fungal
Undecylenic acid 5%Anti-fungal

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

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® Toe & Foot® 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. ■ 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 Emulsifying wax NF, methylparaben, mineral oil, white petrolatum.

PRINCIPAL DISPLAY PANEL

THE ORIGINAL
FUNGI-NAIL®
TOE & FOOT® BRAND

MAXIMUM STRENGTH ANTI-FUNGAL

STOPS SKIN FUNGUS AROUND NAILS

KILLS FUNGUS RESTORES SKIN


CURES Most Athlete's Foot

SKIN PENETRATING OINTMENT

0.7 FL. OZ. (20 g)

Lasting ointment with dual-angled brush

For best results treat around all toenails and in between toes

Not for Nail or scalp fungus

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

Ungüento con aplicador de brocha con doble ángulo

Para mejores resultados aplique Fungi-Nail® alrededor de las uñas, y entre los dedos del pie

Este product no es efectivo en el cuero cabelludo ni en las uñas
 
K0118

Certified
WBENC
Women's Business Enterprise

Kramer Laboratories, Inc.
Coral Gables, FL 33134
kramerlabs.com
funginail.com
1-800-824-4894

carton

NDC#: 55505-179-50

THE ORIGINAL
FUNGI-NAIL®
TOE & FOOT® BRAND

MAXIMUM STRENGTH ANTI-FUNGAL

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
funginail.com
1-800-824-4894

K0317

label
FUNGI NAIL TOE AND FOOT  MS
zinc undecylenate undecylenic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-179
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE4 g  in 20 g
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID1 g  in 20 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-179-501 in 1 CARTON05/11/201604/30/2020
120 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:55505-179-551 in 1 CARTON06/01/201806/30/2020
225 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/11/201606/30/2020
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmecuticals001207208manufacture(55505-179)

Revised: 12/2022
 
Kramer Laboratories