UNDECYLENIC ACID by CVS Pharmacy / Pharma Pac, LLC UNDECYLENIC ACID liquid

UNDECYLENIC ACID by

Drug Labeling and Warnings

UNDECYLENIC ACID by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Section from Carton Label Follows:

Active ingredient                      Purpose
Undecylenic acid 25% w/v.......Antifungal

PURPOSE

Section from Carton Label Follows:

Active ingredient                       Purpose
Undecylenic Acid 25% w/v.................Antifungal

Uses
Treats most athletes foot (tinea pedis)
and ringworm (tinea corporis)

KEEP OUT OF REACH OF CHILDREN

Section from Warnings section of Carton label follows:

KEEP THIS AND ALL MEDICATION OUT
OF THE REACH OF CHILDREN
If accidental ingestion occurs,
immediately contact a physician,
emergency medical facility or Poison
Control Center for help.

INDICATIONS & USAGE

Section from Directions portion of carton label follows:

Directions
- Using soap and water, clean 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.
- Use the brush applicator provided for
easy application to the affected area
- For toe usage, change shoes and socks
at least once daily and wear well fitting,
ventilated shoes
- Pay particular attention to spaces
between the toes for athletes foot
- For athletes foot and ringworm, use the
product daily for 4 weeks. If condition
persists longer, consult a physician
- This product is not effective on the scalp
or nails
- Children must be supervised in the use
of this product

WARNINGS

From Warnings Section of Carton Label:

Warnings For external use only.
______________________________
Ask a doctor before use on children
under 2 years of age
____________________________________
When using this productavoid contact
with the eyes
____________________________________
Stop use and consult a doctor if
- Irritation occurs - you do not notice
improvement within 4 weeks
____________________________________
KEEP THIS AND ALL MEDICATION OUT
OF THE REACH OF CHILDREN
If accidental ingestion occurs,
immediately contact a physician,
emergency medical facility or Poison
Control Center for help.

DOSAGE & ADMINISTRATION

Section from Directions portion of carton label follows:

Directions
- Using soap and water, clean 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.
- Use the brush applicator provided for
easy application to the affected area
- For toe usage, change shoes and socks
at least once daily and wear well fitting,
ventilated shoes
- Pay particular attention to spaces
between the toes for athletes foot
- For athletes foot and ringworm, use the
product daily for 4 weeks. If condition
persists longer, consult a physician
- This product is not effective on the scalp
or nails
- Children must be supervised in the use
of this product

INACTIVE INGREDIENT

From Inactive Ingredients section of Carton Label:

Inactive Ingredients Isopropyl Palmitate

PRINCIPAL DISPLAY PANEL

Carton

INGREDIENTS AND APPEARANCE

UNDECYLENIC ACID 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	288 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)	712 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-132-15	1 in 1 CARTON
1		30 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/01/2008

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture