Label: CAREALL TOLNAFTATE- tolnaftate cream

  • NDC Code(s): 51824-001-01, 51824-001-05
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • PURPOSE

    Antifungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If Swallowed, get medical help or contact a Poison Control center right away.

  • INDICATIONS & USAGE

    • Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • For effective relief of itching, burning and cracking
  • WARNINGS

    For external use only

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot or ring worm) or 2 weeks (for jock itch).

    Do not use on children under 2 years of age unless directed by a doctor

  • DOSAGE & ADMINISTRATION

    •  Wash affected area and dry thoroughly
    • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
    • Supervise children in the use of this product 
    • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shows 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 doctor
    • This product is not effective on scalp or nails
  • INACTIVE INGREDIENT

    Ceteth 20, Cetyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Sorbitan Monostearate, Steryl Alcohol, Purified Water 

  • PRINCIPAL DISPLAY PANEL

    Tolnaftate label

  • INGREDIENTS AND APPEARANCE
    CAREALL TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Ceteth-20 (UNII: I835H2IHHX)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-001-0514 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
    2NDC:51824-001-0128 g in 1 TUBE; Type 0: Not a Combination Product06/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/01/2012
    Labeler - New World Imports, Inc (075372276)
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