Undecylenic Acid by Chemco Corporation UNDECYLENIC ACID liquid

Undecylenic Acid by

Drug Labeling and Warnings

Undecylenic Acid by is a Otc medication manufactured, distributed, or labeled by Chemco Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Undecylenic Acid 25%

PURPOSE

Antifungal

USES:

Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis).

Relieves itching, scaling, cracking, burning, and redness.

WARNINGS

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

EXTREMELY FLAMMABLE:

Keep away from fire or flame.

STOP USE AND ASK A DOCTOR 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.

DIRECTIONS:

Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily 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 and socks 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:

Store at room temperature 15° - 30°C (59° - 86°F)

INACTIVE INGREDIENT

Isopropyl Alcohol, Water (Aqua), Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf Oil.

PRONAIL FUNGUS KILLER

INGREDIENTS AND APPEARANCE

UNDECYLENIC ACID 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49283-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DMDM HYDANTOIN (UNII: BYR0546TOW)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49283-025-05	15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/16/2018

Labeler - Chemco Corporation (032495954)

Registrant - Chemco Corporation (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
Chemco Corporation		032495954	manufacture(49283-025)