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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 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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