ARTIFICIAL TEARS- glycerin solution/ drops 
Preferred Pharmaceuticals 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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GC Artificial Tears 181

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Purpose

Lubricant

Uses

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

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

When using this product

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
remove contact lenses before using

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

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

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

Directions

instill 1 or 2 drops in the affected eye(s) as needed
children under 6 years of age: ask a doctor

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

1-800-540-3765

package label

Artifical Tears Lubricand Eye Drops
ARTIFICIAL TEARS 
glycerin solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7266(NDC:57896-181)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.002 mg  in 1 mg
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED0.002 mg  in 1 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.01 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7266-01 in 1 CARTON03/11/2021
115 mg in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/11/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7266)

Revised: 3/2023
Document Id: 7ffdfb75-35ed-41de-a0ed-80fc5b1d12b7
Set id: dd646c72-8f47-43c6-a734-db0dcc8cd4d1
Version: 3
Effective Time: 20230330
 
Preferred Pharmaceuticals Inc.