Label: UNDECYLENIC ACID liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 11822-0028-7 - Packager: RiteAid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 4, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
