DRY EYE RELIEF- polyethylene glycol and propylene glycol gel 
Cardinal Health, 110 dba LEADER

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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Sterile Dry eye Relief

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%           Lubricant
Propylene Glycol 0.3% Lubricant

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if you experience any of the following:

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

Directions

Other information

Inactive ingredients

 boric acid, edetate disodium , potassium chloride, mangnesium chloride , sodium chloride, sodium borate , purified water.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

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DRY EYE RELIEF 
polyethylene glycol and propylene glycol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0088
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORITE (UNII: G538EBV4VF)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MAGNESIUM CHLORATE (UNII: M536P01U3N)  
POTASSIUM CHLORATE (UNII: H35KS68EE7)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0088-110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/09/2021
Labeler - Cardinal Health, 110 dba LEADER (063997360)

Revised: 6/2021
Document Id: c607d95b-ce97-7367-e053-2995a90ab847
Set id: f8da3af5-9172-4023-be82-0fd5bd891616
Version: 3
Effective Time: 20210630
 
Cardinal Health, 110 dba LEADER