- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNDECYLENIC ACID
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0028 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:11822-0028-7 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 - RiteAid (014578892) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture