Label: RUGBY ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    •
    cures most athlete's foot, jock itch, and ringworm
    •
    relieves itching, burning, cracking, scaling and discomfort
  • Warnings

    For external use only.

    Avoid contact with eyes.

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

    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 for jock itch

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    •
    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 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 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
  • Other information

    •
    store at 15 to 30°C (59 to 86°F)
    •
    Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    RUGBY® LABORATORIES
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Rugby®

    Relabeled By: Preferred Pharmaceuticals Inc.

    NDC 68788-8091-2

    Compare to the
    active ingredient
    of Lotrimin® AF*

    Antifungal Cream
    Clotrimazole 1%

    Cures most athlete's foot

    NET WT 1 OZ (28 g)

    Clotrimazole Cream USP 1% Rugby
  • INGREDIENTS AND APPEARANCE
    RUGBY ANTIFUNGAL CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8091(NDC:0536-1272)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8091-21 in 1 CARTON10/05/2021
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug333C10/05/2021
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8091)
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