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UNDECYLENIC ACID by RiteAid

Dosage form: liquid
Ingredients: UNDECYLENIC ACID 288mg in 1mL
Labeler: RiteAid
NDC Code: 11822-0028

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 facts

Section from Carton Label Follows:

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

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)

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.

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

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.

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

From Inactive Ingredients section of Carton Label:

Inactive Ingredients Isopropyl Palmitate

Carton


UNDECYLENIC ACID 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0028
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID288 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE712 mg  in 1 mL
Packaging
#Item CodePackage Description
1NDC:11822-0028-71 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/2008
Labeler - RiteAid (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

 
RiteAid

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Medically reviewed on Feb 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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