Label: EQUATE SPRING RAIN LIQUID HAND- benzalkonium chloride soap

  • 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 January 12, 2018

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    for washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if

    irritation or redness develops and lasts.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • use to refill a pump bottle.
    • from pump bottle, apply onto wet hands.
    • lather and rinse thoroughly.
  • Other information

    store at room temperature.

  • Inactive ingredients

    Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Lauramine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Benzoate, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Questions or comments?

    1-888-287-1915

  • Labe Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    EQUATE SPRING RAIN LIQUID HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-081
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-081-561656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/11/2018
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(49035-081)
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