Label: OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM- 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 June 15, 2015

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

View All Sections
  • PRINCIPAL DISPLAY PANEL - 125g Can Label

    PRINCIPAL DISPLAY PANEL - 177mL Can Label

    SKIN HYDRATING

    TOPICAL FOAM

    CLO-1

    ANTIFUNGAL FOAM

    Relief for itching

    and burning feet

    Helps support

    skin barrier function

    NET WT. 4.4 OZ (125g)

  • 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 wihin 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 to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. 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, Propylene, glycol, Butane, Palmitic acid, Stearic acid, Propane, PVP, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl acetate, Disodium EDTA, Ubiquinone

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

  • INGREDIENTS AND APPEARANCE
    OCCULUS  SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM
    clotrimazole aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0090
    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)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0090-3125 g in 1 CAN; Type 0: Not a Combination Product
    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 Packaging, Inc.805987059label(13630-0090) , pack(13630-0090)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0090)
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!