CAREALL ARTIFICAL TEARS- glycerin, hypromellose, polyethylene glycol 400 solution/ drops 
New World Imports, Inc

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.

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DRUG FACTS

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Lubricant

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

For the temporary relief of burning and irritation due to dryness of the eye.  For protection against further irritation.

When using this product

  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye last
  • condition worsens or lasts more than 72 hours

If pregnant or breast-feeding,ask a health professional before use

Put 1 to 2 drops in the affected eye(s) up to 4 times daily.  Children under 6 years of age: ask a doctor

Some users may experience a brief tingling sensation

benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

Distributed by: NWI, Inc.  160 Athens Way.  Nashville, TN 37228

(615)329-1906

ED5 label

CAREALL ARTIFICAL TEARS 
glycerin, hypromellose, polyethylene glycol 400 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-038
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES2 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
DEXTROSE (UNII: IY9XDZ35W2)  
GLYCINE (UNII: TE7660XO1C)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-038-0515 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201410/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/01/201410/14/2021
Labeler - New World Imports, Inc (075372276)

Revised: 10/2021
 
New World Imports, Inc