Fungi Nail Toe and Foot by Kramer Laboratories / Denison Pharmecuticals

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 Kramer Laboratories, Denison Pharmecuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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Undecylenic acid 5%

Zinc Undecylenate 20%

Antifungal

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.

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.

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. ■ 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.

Emulsifying wax NF, methylparaben, mineral oil, propylparaben, white petrolatum

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.

FUNGI NAIL TOE AND FOOT  MS
zinc undecylenate undecylenic acid ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	20 g  in 20 g
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	5 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
STEARETH-20 (UNII: L0Q8IK9E08)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-174-50	20 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2012	10/07/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/01/2012	10/07/2015

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmecuticals		001207208	manufacture(55505-174)

Revised: 1/2018

Document Id: b82cee51-36bb-4b42-866c-6812810dccaf

34390-5

Set id: 286e613e-3ebb-4e06-b773-6c3de59af41f

Version: 5

Effective Time: 20180116