Label: EQUATE DAY AND NIGHT RESTORE TEARS- mineral oil, white petrolatum and carboxymethylcelluose sodium kit

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 7, 2018

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  • SPL UNCLASSIFIED SECTION

    Walmart

    Equate

    Day & Night Restore Tears

    15mL & 3.5g

    NDC 49035-883-59

    Restore PM Lubricant Eye Ointment NDC# 49035-191-50

    Drug Facts

  • Active ingredients

    Mineral Oil 42.5% and White Petrolatum 57.3%

  • Purpose

    Lubricant

  • Uses

    • for the temporary relief of burning, irritation and discomfort due to dryness of the eye.
    • exposure to wind or sun
    • may be used as a protectant against further irritation.
  • Warnings

    • For use in the eyes only.
    • Retain outer carton for full product drug facts.

    When using this product

    • avoid contamination, do not touch tip of container to any surface.
    • replace cap after use.

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye.
    • the condition worsens or persists for more than 72 hours.

    If pregnant or breast feeding,

    ask a health professional before use. 

    Keep this and all drugs out of the reach of children. 

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • pull down lower lid of eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid, every 3-4 hours or as directed by doctor.
  • Other information

    • Do not use if bottom ridge of tube cap is exposed, and if imprinted seals on side flaps are not intact and completely legible • store at room temperature 15°-30°C (59°-86°F)
    • store away from heat
    • keep from freezing
    • see crimp of tube or box for lot number and expiration date
  • Inactive ingredients

    lanolin alcohols

    Walmart

    Equate

    Day & Night Restore Tears

    15mL & 3.5g

    NDC 49035-883-59

    Restore Tears Lubricant Eye Drops NDC 49035-189-13

    Drug Facts

  • Active ingredients

    Carboxymethylcellulose Sodium 0.5%

  • Purpose

    Eye Lubricant

  • Uses

    • for the temporary relief of burning, irritation and discomfort due to dryness of the eye.
    • exposure to wind or sun
    • may be used as a protectant against further irritation.
  • Warnings

    • For use in the eyes only.
    • Retain outer carton for full product drug facts.

    Do not use

    • if this product changes color or becomes cloudy.

    When using this product

    • avoid contamination, do not touch tip of container to any surface.
    • replace cap after use.

    Stop use and ask a doctor if  

    • you experience eye pain, changes in vision, continued redness or irritation of the eye.
    • the condition worsens or persists for more than 72 hours.

    Keep this and all drugs out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Other information

    • Do not use if imprinted seal on cap is torn, broken or missing
    • store at room temperature 15°-30°C (59°-86°F)
    • keep tightly closed
  • Inactive ingredients

    Boric Acid, calcium chloride, magnesium chloride, potassium chloride, sodium borate, water for injection. Vanish® (Stabilized Peroxycomplex System as a preservative). May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-883-59
    Equate
    Day & Night
    Restore Tears
    15mL & 3.5g

    PRINCIPAL DISPLAY PANEL NDC 49035-883-59 Equate Day & Night Restore Tears 15mL & 3.5g

  • INGREDIENTS AND APPEARANCE
    EQUATE DAY AND NIGHT RESTORE TEARS 
    mineral oil, white petrolatum and carboxymethylcelluose sodium kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-883
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-883-591 in 1 CARTON; Type 1: Convenience Kit of Co-Package06/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 15 mL
    Part 21 TUBE 3.5 g
    Part 1 of 2
    RESTORE TEARS LUBRICANT EYE 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34906/01/2018
    Part 2 of 2
    RESTORE PM LUBRICANT EYE 
    mineral oil, petrolatum ointment
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL425 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM573 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34906/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34906/01/2018
    Labeler - Wal-Mart Stores, Inc. (051957769)
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