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DERMAN ANTIFUNGAL by Teresa Cecena DBA Genesis

Medically reviewed on May 21, 2018

Dosage form: cream
Ingredients: UNDECYLENIC ACID 5g in 100g, ZINC UNDECYLENATE 18g in 100g
Labeler: Teresa Cecena DBA Genesis
NDC Code: 69772-125

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.

ACTIVE INGREDIENTS.

Zinc undercylenate 18%

undecylenic acid 5%

PURPOSE

Antifungal

USES

For the treatment of athlete's foot. Relieves itching-scaling-cracking-buring.

AVOID CONTACT WITH EYES

Keep this and all drugs out od the reach of children. In case of accidental ingestion. seel professional assistance or contact a poison control center immediately.

Do not use in pregnancy and children under 2 years of age unless directed by a physician.

For external use only

In case of accidental ingestion seek professional assistance or contac a poison control center immediately.

Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.

This product is not effective on the scalp or nails.

Polyethylene Glyctol 500, polythylene glycol 4000, water, glycerin, cetyl alcohol, propylene, gycol, zinc stearate, nonyl phenol sulfate, sodium bisulfite.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.

This product is not effective on the scalp or nails

DERMAN ANTIFUNGAL 
zinc undecylenate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID5 g  in 100 g
ZINC UNDECYLENATE (UNDECYLENIC ACID) ZINC UNDECYLENATE18 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
POLYETHYLENE GLYCOL 500 
POLYETHYLENE GLYCOL 4000 
GLYCERIN 
CETYL ALCOHOL 
PROPYLENE GLYCOL 
WATER 
ZINC STEARATE 
SODIUM BISULFITE 
Packaging
#Item CodePackage Description
1NDC:69772-125-021 TUBE in 1 CARTON
1NDC:69772-125-0125 g in 1 TUBE
2NDC:69772-125-031 TUBE in 1 CARTON
250 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/14/2015
Labeler - Teresa Cecena DBA Genesis (078760958)
Registrant - Teresa Cecena (078760958)
Establishment
NameAddressID/FEIOperations
Teresa Cecena DBA Genesis078760958relabel(69772-125)
Establishment
NameAddressID/FEIOperations
COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I.DE C.V.815039995manufacture(69772-125)

 
Teresa Cecena DBA Genesis

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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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