ARTIFICIAL TEARS- glycerin, hypromellose, polyethylene glycol 400 liquid 
American Sales Company

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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CareOne Artificial Tears

Active Ingredient

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene Glycol 400 1%

Purpose

Lubricant

Lubricant

Lubricant

Uses


Warnings


Do not use this product if

solution changes color or becomes cloudy

Stop use and ask a doctor if you experience

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

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
  • remove contact lens before using

Keep out of reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

Inactive ingredients

aminoacetic acid, ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

Package principal display panel

Care One Tears

carton

ARTIFICIAL TEARS 
glycerin, hypromellose, polyethylene glycol 400 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-865
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
DEXTROSE (UNII: IY9XDZ35W2)  
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)  
GLYCINE (UNII: TE7660XO1C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-865-051 in 1 BOX09/10/2010
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/06/2010
Labeler - American Sales Company (809183973)

Revised: 10/2019
Document Id: 9602d650-fc3f-0931-e053-2995a90a8058
Set id: 4c62432b-bd6d-46ac-a5fb-8dadfda04846
Version: 4
Effective Time: 20191028
 
American Sales Company