085 LUBRICATING EYE DROPS- lubricating eye drops solution/ drops 
OTE North America

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Warnings for External use only. HydroPure Box

Inactive ingredients: borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyaluronate

HydroPure box inactive ingredients

Uses

*For the temporary relief of burning and irritation due to dryness of the eye * For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun * For use as a protectant against further irritation or to temporarily relieve dryness of the eye HydroPure Box Uses section

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

HydroPure box Keep out of reach section

I am not sure what is meant by purpose. There are the uses which is this section:

Uses

*For the temporary relief of burning and irritation due to dryness of the eye * For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun * For use as a protectant against further irritation or to temporarily relieve dryness of the eye

Then in the active ingredients section it describes the purpose like this:

Active ingredient Purpose

Glycerin 0.25%................................... Eye Lubricant

HydroPure box uses section

Active ingredient Purpose

Glycerin 0.25%................................... Eye Lubricant

HydroPure box active ingredient

HydroPure box and label Page 1.jpg

HydroPure box and label Page 2.jpg HydroPure box HydroPure label

085 LUBRICATING EYE DROPS 
lubricating eye drops solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84227-851
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LEVOCARNITINE (UNII: 0G389FZZ9M)  
BORATE ION (UNII: 44OAE30D22)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84227-851-101 in 1 CARTON05/15/2024
110 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 DrugM01805/15/2024
Labeler - OTE North America (963905034)

Revised: 5/2024
Document Id: 186dd836-7af0-5a89-e063-6294a90ada07
Set id: 17f5b6e5-dc14-45c7-e063-6294a90af43d
Version: 2
Effective Time: 20240514
 
OTE North America