GOODSENSE ULTRA LUBRICANT- polyethylene glycol 400, and propylene glycol solution/ drops 
Geiss, Destin & Dunn, Inc

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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Active ingredients                              Purpose

Polyethlene glycol 400 0.4%.............Eye lubricant

Propylene glycol 0.3%.......................Eye lubricant

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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, calcium chloride, chlorhexidine gluconate, hydrochloric acid, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

Distributed By:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

1-866-696-0957

Made in Korea

image description

GOODSENSE ULTRA LUBRICANT 
polyethylene glycol 400, and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-821
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
BORIC ACID (UNII: R57ZHV85D4)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-821-151 in 1 BOX05/18/2017
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 finalpart34905/18/2017
Labeler - Geiss, Destin & Dunn, Inc (076059836)

Revised: 5/2017
Document Id: 08be22d8-4f39-44e3-96e8-61e7fb073fc4
Set id: e9e60c83-5cf1-4af8-bbc2-40c667c2317b
Version: 1
Effective Time: 20170517
 
Geiss, Destin & Dunn, Inc