EYE DROPS - glycerin solution 
Opto-Pharm Pte Ltd

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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Drug Facts

Active Ingredient

Glycerin.....1.0%

Purpose


Lubricant


Uses

Warnings

For external use only

Do not use 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

Stop use and 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 or persists for more than 72 hours

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other informations

Inactive ingredients

boric acid, citric acid, hypromellose, N-acetyl-carnosine, potassium bicarbonate, purified benzyl alcohol, sterile water

Questions

+65-68614801

Principal Display Panel

NDC 46823-001-05

STERILE LUBRICANT EYE DROPS


2X0.17 fl oz/5 ml vials

(Net 0.34 fl oz/10 ml)

Label


EYE DROPS 
glycerin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46823-001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
N-ACETYLCARNOSINE (UNII: 0TPN86OQIF)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46823-001-0510 g in 1 VIAL; Type 0: Not a Combination Product03/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/06/2017
Labeler - Opto-Pharm Pte Ltd (595239682)
Registrant - Opto-Pharm Pte Ltd (595239682)

Revised: 3/2017
Document Id: b63c7831-9543-42ed-9991-79bd796a543a
Set id: 078b9b91-9161-415e-9994-58940b9dfe1e
Version: 1
Effective Time: 20170306
 
Opto-Pharm Pte Ltd