CAREONE ULTRA LUBRICANT- polyethylene glycol 400, and propylene glycol solution/ drops 
FOODHOLD U.S.A., LLC

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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CareOne Ultra Lubricant Eye Drops 0.5oz (NBE Systane Ultra)

Active ingredients                        Purpose

Polyethylene glycol 400 0.4%.......Eye lubricant

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

Uses

  • 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
  • replace cap after each use

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

  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed

Other information

  • store at room temperature

Inactive ingredients

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

Distributed by:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

© 2017 S&S Brands, LLC

Quality guaranteed or 

your money back.

Made in Korea

image description

CAREONE ULTRA LUBRICANT 
polyethylene glycol 400, and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-535
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:41520-535-151 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 finalpart34905/18/201711/12/2019
Labeler - FOODHOLD U.S.A., LLC (809183973)

Revised: 11/2021
Document Id: d10629d6-175c-5070-e053-2a95a90aaf27
Set id: 0a6e904c-334b-47bc-a757-7f03e6aad73e
Version: 4
Effective Time: 20211117
 
FOODHOLD U.S.A., LLC