Label: TINEACIDE PHYSICIAN FORMULA- undecylenic acid cream
TINEACIDE- undecylenic acid cream

  • 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 January 21, 2011

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  • Active Ingredients

    Undecylenic Acid
  • Inactive Ingredients

    Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, Lavender Oil, Methylparaben, PEG-100, Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water

  • Uses

    Cures Athlete's Foot (tinea pedis) jock itch (tinea cruris) and ringworm (tinea corporis).

  • Uses

    For effective relief of itching, cracking, burning and discomfort which can accompany these conditions.
  • Ask Your Physician

    Do not use on children under 2 years of age unless directed by a physician
  • When Using This Product

    Wash the affected area with soap and water and dry thoroughly.  Apply sparingly over affected area twice daily (morning and night) or as directed by a physician.  For athlete's foot pay special attention to spaces between the toes.  wear well-fitting ventilated shoes and change shoes and socks at least once daily.  For athlete's foot and ringworm use daily for 4 weeks.  for jock itch use daily for 2 weeks.  If condition persists longer, consult a physician.

  • Warnings

    For external use only.  Avoid contact with eyes.  If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch) discontinue use and consult a physician.  Keep this and all drugs out of the reach of children.  In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

  • Tineacide Label

    Tineacide Antifungal Cream  Physician Formula
    Dispensed by a physician only.
    1.25 Ounce Label

    1.25 Ounce Label - Physician Formula



  • INGREDIENTS AND APPEARANCE
    TINEACIDE PHYSICIAN FORMULA 
    undecylenic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CLOTRIMAZOLE (UNII: G07GZ97H65)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65373-100-0135.4 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/1995
    TINEACIDE 
    undecylenic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CLOTRIMAZOLE (UNII: G07GZ97H65)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65373-500-0135.4 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/1995
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture
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