Label: HEALTHY ACCENTS ANTIBACTERIAL WASH- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 March 9, 2016

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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. If contact occurs, rinse thoroughly with water.

    Stop using this product 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

    Squeeze onto wet hands or body sponge, work into a lather, wash skin, rinse and dry thoroughly.

  • Questions? Comments?

    1-866-322-2439

  • Inactive ingredients

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

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  • INGREDIENTS AND APPEARANCE
    HEALTHY ACCENTS ANTIBACTERIAL WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-815
    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)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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:55316-815-24710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/08/2016
    Labeler - DZA BRANDS LLC (090322194)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55316-815)
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