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

Equate Day and Night Restore Tears by

Drug Labeling and Warnings

Equate Day and Night Restore Tears by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-883

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-883-59	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	06/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	15 mL
Part 2	1 TUBE	3.5 g

Part 1 of 2

RESTORE TEARS LUBRICANT EYE 
carboxymethylcellulose sodium solution/ drops

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Kind	Ingredient Name	Quantity
May contain	HYDROCHLORIC ACID (UNII: QTT17582CB)
May contain	SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	06/01/2018

Part 2 of 2

RESTORE PM LUBRICANT EYE 
mineral oil, petrolatum ointment

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	425 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	573 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	06/01/2018

Labeler - Wal-Mart Stores, Inc. (051957769)