QC ULTRA LUBRICANT EYE- polyethylene glycol 400, and propylene glycol solution/ drops 
Chain Drug Marketing Association 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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QC Lubricant Eye Drops 25ct NBE Systane Ultra 99556

Active ingredients                                           Purpose
Polyethylene glycol 400 0.4%.............................Lubricant
Propylene glycol 0.3%.........................................Lubricant

Use

  • For the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep out of reach of children

If 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 information

  • Store at room temperature

Inactive ingredients

aminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium hydroxide, sorbitol, water for injection

Distributed by:

C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376--0995

www.qualitychoice.com

Made in Korea

image description

QC ULTRA LUBRICANT EYE 
polyethylene glycol 400, and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-634
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BORIC ACID (UNII: R57ZHV85D4)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-634-0425 in 1 CARTON09/30/2016
10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/30/201611/09/2021
Labeler - Chain Drug Marketing Association Inc (011920774)

Revised: 11/2021
 
Chain Drug Marketing Association Inc