EYES IRRITATION RELIEF- polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid 
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 Eyes Irritation Relief Triple Action

Drug Facts

Active ingredients

Polyvinyl alcohol 0.5%

Active ingredients

Povidone 0.6%

Purpose

Lubricant

Active ingredient

Tetrahydrozoline hydrochloride 0.05%

Purpose

Redness reliever

Uses

Warnings

For external use only

Do not use if

solution changes color or becomes cloudy.

Ask a doctor before use if you have

narrow angle glaucoma.

When using this product

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

Stop use & ask a doctor if

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens
  • symptoms last for more than 72 hours

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 to 2 drops in the affected eye(s) up to four times daily.

Other information

Inactive ingredients

Benzalkonium Chloride,  Disodium Hydrogen Phosphate Anhydrous, Disodium Edetate, Mannitol , Potassium Chloride, Purified Water, Sodium dihydrogen Phosphate Dihydrate, Sodium Chloride, Sodium Citrate , May Contain Hydrochloric Acid and/or Sodium Hydroxide to Adjust PH.

PRINCIPAL DISPLAY PANEL

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EYES IRRITATION RELIEF 
polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0087
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0087-11 in 1 BOX03/09/2021
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
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: c607e19d-2eb4-cb87-e053-2995a90ab785
Set id: bd2608c6-ffdf-352a-e053-2995a90a26a8
Version: 2
Effective Time: 20210630
 
Cardinal Health, 110 dba LEADER