Label: TOPCARE EVERYDAY SPRING FRESH BODY WASH- benzalkonium chloride liquid

  • 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 October 31, 2019

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Use

    For washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop using this product and ask a doctor if

    irritation and 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

    Squeeze a small amount onto a wet wash cloth, sponge, pouf or hands and apply to body. Work into a rich lather and rinse off.

  • Questions or comments?

    1-888-423-0139

  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Decyl Glucoside, Hydroxyethylcellulose, Glycerin, Poloxamer 124,  Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Propylene Glycol, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    TOPCARE EVERYDAY SPRING FRESH BODY WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-895
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-895-18532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/30/2019
    Labeler - Topco Associates LLC (006935977)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(36800-895)
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