Label: LUCKY SUPERSOFT ATHLETES FOOT- clotrimazole 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 December 20, 2020

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

View All Sections
  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    ■ cures most athlete's foot, jock itch, and ringworm ■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

  • Warnings

    For external use only.

  • Do not use

    children under 2 years of age unless directed by a doctor

  • When using this product

    avoid contact with eyes

  • Stop use and ask a doctor if

    ■ irritation occurs ■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (jock itch)

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    ■ wash affected area and dry thoroughly ■ apply a  thin layer over affected area twice daily  (morning and night) ■ supervise children in the use of this product ■ 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 a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if conditions persist longer, ask a doctor ■ this product is not effective on the scalp or nails.

  • Other Information

    ■  store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive Ingredients

    benzyl alcohol, cetearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, stearyl alcohol, water

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPERSOFT  ATHLETES FOOT
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47046-173-0142.5 g in 1 TUBE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/31/2015
    Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!