Label: OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1- clotrimazole aerosol, foam

  • 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 17, 2020

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  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • For the treatment of most athlete's foot (tinea pedis) or ringworm (tinea corporis).
    • For effective relief of redness, irritation, scaling, cracking, itching, burning feet.
  • Warnings

    For external use only

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

    When using this product: • Avoid contact with the eyes. • Do not use on deep or puncture wounds, infections or lacerations.

    Stop use and ask a doctor if

    • Irritation occurs or if there is no improvement within 4 weeks.

    Contents under pressure. Protect from heat and direct sunlight. Do  not puncture or incinerate. Do not store at temperatures above 120°F. If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

  • Directions

    • Hold can upright. Shake well before each application.
    • Clean the affected area and dry thoroughly.
    • Apply a thin layer of the product 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 shoes, and change shoes and socks at least once daily.
    • For athlete's foot and ringworm, use daily for 4 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
  • Inactive Ingredients

    Water, Cetearyl ethylhexanoate, Butane, Propylene glycol, Palmitic acid, Propane, Stearic Acid, PVP, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl Acetate, Disodium EDTA, Ubiquinone

  • Questions or comments? Call toll free 1-855-317-1107

  • PRINCIPAL DISPLAY PANEL - 125 g Can Label

    PRINCIPAL DISPLAY PANEL - 125g Can Label

    SKIN HYDRATING

    TOPICAL FOAM

    CLO-1

    ANTIFUNGAL FOAM

    Relief for itching

    and burning feet


    NET WT. 4.4 OZ (125g)

  • INGREDIENTS AND APPEARANCE
    OCCULUS  SKIN HYDRATING TOPICAL FOAM CLO-1
    clotrimazole aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0092-3125 g in 1 CAN; Type 0: Not a Combination Product08/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/01/2015
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0092) , analysis(13630-0092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0092) , pack(13630-0092)
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