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SANAFITIL by Tarmac Products, Inc

Dosage form: ointment
Ingredients: Undecylenic Acid 100mg in 1g
Labeler: Tarmac Products, Inc
NDC Code: 11096-190

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.

SANAFITIL®
OINTMENT

Drug Facts

Active Ingredients

Undecylenic Acid 10%

Purpose

Antifungal

Uses
  • For the treatment of most athlete's foot, jock itch & ringworm
  • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warning
  • For external use only.

  • When using this product avoid contact with eyes and mucous membrane.

  • Do not use on children under 2 years of age except under the advice and supervision of a doctor.
  • Not for diaper rash

Stop use and ask a doctor if
  • Irritation occurs
  • There is no improvement within 4 weeks of treatment for athlete's foot and ringworm and 2 weeks of treatment for jock itch discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion seek professional assistance or contact a poison control center right away.

Directions
  • Clean affected area and dry thoroughly.
  • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor.
  • For athlete's foot pay special attention to the space between the toes. Wear well fitting, ventilated shoes and change shoes & socks at least once a day.
  • For athlete's foot and ringworm, use daily for 4 weeks
  • For jock itch use daily for 2 weeks.
  • Supervise Children in use of this product.
  • Product not effective in the scalp or nails.

Other Information

Store at 59° - 86° F (15°- 30°C)

Other ingredients

petrolatum white, benzocaine, paraffin wax, salicylic acid, benzoic acid, boric acid, methyl salicylate, methyl paraben, propyl paraben, menthol crystals

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

SANAFITIL®

(Undecylenic Acid 10%)

ANTIFUNGAL

OINTMENT

1 OZ. (28.35g)

SANAFITIL 
undecylenic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11096-190
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (Undecylenic Acid) Undecylenic Acid100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
BENZOCAINE 
PARAFFIN 
HEXYL SALICYLATE 
BENZOIC ACID 
BORIC ACID 
METHYL SALICYLATE 
METHYLPARABEN 
PROPYLPARABEN 
MENTHOL 
Packaging
#Item CodePackage Description
1NDC:11096-190-011 TUBE in 1 CARTON
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/24/1966
Labeler - Tarmac Products, Inc (059890491)
Establishment
NameAddressID/FEIOperations
Tarmac Products, Inc059890491MANUFACTURE(11096-190)

Revised: 04/2013
 
Tarmac Products, Inc

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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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