UNDECYLENIC ACID- anti-fungal liquid maximum strength liquid

Undecylenic Acid by

Drug Labeling and Warnings

Undecylenic Acid by is a Otc medication manufactured, distributed, or labeled by Hudson Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Undecylenic acid 25%w/w

Purpose

Antifungal

Uses

For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).

For relief of:

discomfort which may accompany these conditions
itching
burning
redness
irritation
scaling
soreness

Warnings

For external use only.

If pregnant or breastfeeding

consult a healthcare professional before use.

Do not use

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

When using this product

avoid contact with eyes

Use only as directed

by a doctor on persons with highly sensitive skin.

Stop use and consult a doctor if

• there is no improvement within 4 weeks
• irritation occurs

Keep out of children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

Read all warnings and directions. Use only as directed.

• clean the affected area and dry thoroughly
• apply a thin layer of the product over the affecter 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 toeswear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor
• this product is not effective on the scalp or nails

Other information

• store at room temperature 15°-30°C (59° - 86°F)
• protect from freezing. If freezing occurs warm to room temperature
• keep tightly closed when not in use

Inactive ingredient

isopropyl palmitate

Questions?

Call 1-877-237-0194

Principal Display Panel

comfortzone

maximum strength

anti-fungal liquid

undecylienic acid

eliminates fungus on fingers, toes & around nails

• easy to apply applicator brush
• dries quickly
• non-oily, clear formula
• no unpleasant odor

NET 1 FL. OZ (30mL)

INGREDIENTS AND APPEARANCE

UNDECYLENIC ACID 
anti-fungal liquid maximum strength liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72446-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	7.5 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72446-004-01	30 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/01/2018

Labeler - Hudson Health LLC (081276171)