Label: SANAFITIL- undecylenic acid ointment

  • 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 April 30, 2013

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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)

    Principal Display Panel - 28.35 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SANAFITIL 
    undecylenic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11096-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    BENZOCAINE (UNII: U3RSY48JW5)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BORIC ACID (UNII: R57ZHV85D4)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11096-190-011 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/FEIBusiness Operations
    Tarmac Products, Inc059890491MANUFACTURE(11096-190)