EMONINAIL ANTIFUNGAL- undecylenic acid liquid

EmoniNail Antifungal by

Drug Labeling and Warnings

EmoniNail Antifungal by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Undecylenic Acid 10.00%

Purpose

Topical Antifungal

Uses

Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).

Warnings

• For external use only

Do not use

• on children under 2 years of age, unless directed by a doctor.

Stop use and ask a doctor if,

• If irritation occurs or if there is no improvement within 4 weeks.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

When using this product,

avoid contact with eyes.

Directions

• Wash the affected area and dry thoroughly.
• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
• Supervise children in the use of this product.
• For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes andsocks at least once daily.
• For athlete's foot and ringworm: use daily for 4 weeks. If condition persists longer, consult a doctor.
• This product is not effective on the scalp or nails.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aqua (Deionized Water), SD-Alcohol 40B, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Alcohol, Polysorbate-20, Polycrylamide, C13-C14 Isoparaffin, Laureth-7, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Ethylhexyglycerin.

Other information

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

INGREDIENTS AND APPEARANCE

EMONINAIL ANTIFUNGAL 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-071-08	24 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/01/2020

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-071)