CVS SINGLE USE LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BERSHTEL ENTERPRISES LLC]

CVS SINGLE USE LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BERSHTEL ENTERPRISES LLC]
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NDC 10564-6553-0
Set ID 66628bfd-be85-7143-e053-2a91aa0a1f41
Category HUMAN OTC DRUG LABEL
Packager Bershtel Enterprises LLC
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredients PurposePolyethylene glycol 400 0.4%......................................LubricantPropylene glycrol 0.3%...............................................Lubricant

  • PURPOSE

    UseFor the temporary relief of burning and irritation due to dryness of the eye

  • WARNINGS

    Warnings For external use only.

  • DO NOT USE

  • WHEN USING

    When using this productdo not touch tip of container to any surface to avoid contaminationdo not reuseonce opened, discard

  • STOP USE

    Stop use and ask a doctor ifyou feel eye painchanges in vision occurredness or irritation of the eye(s) get worse, persists or lasts more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Ophthalmic - Administration to the external eye.

  • INDICATIONS & USAGE

    Directions Instill 1 or 2 drops in the affected eye(s) as needed.

  • STORAGE AND HANDLING

    Other information Store at room temperature. Protect from light.

  • INACTIVE INGREDIENT

    Inactive ingredientsaminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium chloride, sodium hydroxide, sorbitol, water for injection

  • PRINCIPAL DISPLAY PANEL

    CVS eye drops

  • INGREDIENTS AND APPEARANCE
    CVS SINGLE USE LUBRICANT EYE DROPS 
    polyethylene glycol 400, and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-6553
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10564-6553-01 in 1 CARTON; Type 0: Not a Combination Product01/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/21/2016
    Labeler - Bershtel Enterprises LLC (066659129)

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