Rite Aid Fungal

Dosage form: liquid
Ingredients: UNDECYLENIC ACID 288mg in 1mL
Labeler: Rite Aid Corporation
NDC Code: 11822-0250

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




RITE AID FUNGAL  
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0250
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:11822-0250-11 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 - Rite Aid Corporation (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 02/2011
 
Rite Aid Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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