CVS SINGLE USE LUBRICANT EYE DROPS- polyethylene glycol 400, and propylene glycol solution/ drops 
Bershtel Enterprises LLC

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.

----------

Active ingredients PurposePolyethylene glycol 400 0.4%......................................LubricantPropylene glycrol 0.3%...............................................Lubricant

UseFor the temporary relief of burning and irritation due to dryness of the eye

Warnings For external use only.

When using this productdo not touch tip of container to any surface to avoid contaminationdo not reuseonce opened, discard

Stop use and ask a doctor ifyou feel eye painchanges in vision occurredness or irritation of the eye(s) get worse, persists or lasts more than 72 hours

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

Ophthalmic - Administration to the external eye.

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

Other information Store at room temperature. Protect from light.

Inactive ingredientsaminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium chloride, sodium hydroxide, sorbitol, water for injection

CVS eye drops

CVS SINGLE USE LUBRICANT EYE DROPS 
polyethylene glycol 400, and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-6553
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BORIC ACID (UNII: R57ZHV85D4)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10564-6553-01 in 1 CARTON; Type 0: Not a Combination Product01/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/21/2016
Labeler - Bershtel Enterprises LLC (066659129)

Revised: 3/2018
Document Id: 66628bfd-be86-7143-e053-2a91aa0a1f41
Set id: 66628bfd-be85-7143-e053-2a91aa0a1f41
Version: 1
Effective Time: 20180301
 
Bershtel Enterprises LLC