Label: CVS PHARMACY FRESH WATER- 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 May 8, 2014

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.13%

    PURPOSE

    ANTIBACTERIAL

  • USES

    HELPS REDUCE BACTERIA ON THE SKIN

  • WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES 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

    APPLY ONTO WET HANDS. WORK INTO LATHER, RINSE THOROUGHLY AND DRY

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

  • INACTIVE INGREDIENTS

    ALOE BARBADENSIS LEAF JUICE, BLUE 1 (CI 42090), CITRIC ACID, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, EXT. VIOLET 2 (CI 60730), FRAGRANCE (PARFUM), GLYCERIN, HYDROXYETHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POLOXAMER 124, POLYQUATERNIUM-7, SODIUM CITRATE, SODIUM HYDROXIDE, TETRASODIUM EDTA, WATER (AQUA)

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  FRESH WATER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-723
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-723-641890 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/07/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(59779-723)
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