STERILE SALINE EYEWASH- water solution 
Tongzhou Deqi Medical Products Factory

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 Fact

Active Ingredient

water 98.7%

Purpose

eyewash

Warnings

Do not use if solution changes color or becomes cloudy.remove contact lenses before use.stop use if eye pain continued redness or irritation of eye .

Keep out of reach of children.

Keep out of reach of children.in case of axxidental ingestion,seek professional assistance or consult a poison control center immediately.

Directions

Twist top to open,Flush eye as needed.

Use

for irrigating the eye to help relieve irritation by removeing loose foreign material.

Inactive Ingredients

Sodium chloride ,Potassium phosphate monobasic ,Sodium hydroxide,POLIHEXANIDE

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STERILE SALINE EYEWASH 
water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71222-006
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER0.987 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE (UNII: 322U039GMF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71222-006-0110 mL in 1 PACKAGE; Type 0: Not a Combination Product05/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/20/2014
Labeler - Tongzhou Deqi Medical Products Factory (544464252)
Establishment
NameAddressID/FEIBusiness Operations
Tongzhou Deqi Medical Products Factory544464252manufacture(71222-006)

Revised: 6/2017
Document Id: 50e33053-55f4-29f8-e054-00144ff8d46c
Set id: 4952a90a-eee7-30ab-e054-00144ff8d46c
Version: 2
Effective Time: 20170601
 
Tongzhou Deqi Medical Products Factory