Label: FOOTSPA PEDI- alcohol spray

  • NDC Code(s): 49283-707-01, 49283-707-04, 49283-707-16
  • Packager: CHEMCO CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 8, 2023

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%v/v

  • PURPOSE

    Antimicrobial

  • USES:

    To decrease bacteria on the skin.

  • WARNINGS

    • For external use only.

    • Avoid contact with eyes or mucous membrane.

    • Do not apply to wounds or damaged
    skin with a heating pad or on a child
    under 12 year of age.

  • FLAMMABLE:

    Keep away from fire or flame.

  • ASK A DOCTOR BEFORE USE IF

    If you have redness over affected area.

  • STOP USE

    Condition persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help, or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults and children 12 years of age or older
    • Spray two to three pumps or as
    necessary to cover the affected area
    not more than three to four times
    daily.

  • INACTIVE INGREDIENT

    Water (Aqua), Camphor, Polysorbate 20, Menthol, DMDM Hydantoin, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, D&C Yellow No.11(CI 47000), FD&C Blue No.1 (CI 42090).

  • QUESTIONS

    Contact us
    +1 (305) 623-4445

  • FOOTSPA - ANTIBACTERIAL PEDI SPRAY 4 oz

    PEDI SPRAY 4

  • FOOTSPA - ANTIBACTERIAL PEDI SPRAY 16 oz

    PEDI SPRAY 16

  • FOOTSPA - ANTIBACTERIAL PEDI SPRAY 128 oz

    PEDI SPRAY 1

  • INGREDIENTS AND APPEARANCE
    FOOTSPA PEDI 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-707
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MENTHOL (UNII: L7T10EIP3A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-707-16473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/08/2023
    2NDC:49283-707-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/08/2023
    3NDC:49283-707-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/17/2021
    Labeler - CHEMCO CORPORATION (032495954)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(49283-707)
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