EYE WASH SALINE (WATER SODIUM CHLORIDE) SOLUTION [DAVEMED HEALTHCARE CO., LTD.]

EYE WASH SALINE (WATER SODIUM CHLORIDE) SOLUTION [DAVEMED HEALTHCARE CO., LTD.]
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NDC 70897-002-01, 70897-002-02, 70897-002-03, 70897-002-04
Set ID 39a7b408-7601-2d66-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Davemed Healthcare Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART349
  • Purpose

    Eye, wounds wash

  • Active ingredient

    Purified water, sodium Chloride

  • Uses

    For tocipal irrigation of eyes, burns and wounds

  • Warnings

    Use only if Solution is clear and container is undamaged

    Do not heat over 66°C (150 F). Store at a cool dry place

    Discard any unused solution. Single use only

    Keep out of reach of children.

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

  • Directions

    Not for injection

  • Inactive ingredients

    boric acid, sodium borate, sodium chloride, Hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    EYE WASH SALINE 
    water sodium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-002
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 mg  in 100 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.01 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBIC ACID (UNII: X045WJ989B)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-002-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2016
    2NDC:70897-002-0220 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2016
    3NDC:70897-002-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2016
    4NDC:70897-002-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/09/2016
    Labeler - Davemed Healthcare Co., Ltd. (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd529128716manufacture(70897-002)

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