MAJOR LUBRICATING EYE DROPS- carboxymethylcellulose sodium solution/ drops 
Harvard Drug Group L L C

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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Major Lubricating Eye Drops 30ct and 50ct

Active ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Lubricant

Uses

Warnings

For external use only

Do not use this product if

  • solution changes color or becomes cloudy

When using this product

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

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye continues
  • redness or irritation of the eye worsens or persists for more than 72 hours

Keep out of the reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Other information

Inactive ingredients

calcium chloride, **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate. **May contain these ingredients to adjust pH.

Questions or comments?

Call (800) 616-2471

Major Lubricating Eye Drops 30ct

Major Lubricating Eye Drops 30ct

Major Lubricating Eye Drops 50ct

Major Lubricating Eye Drops 50ct

MAJOR LUBRICATING EYE DROPS 
carboxymethylcellulose sodium solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6848
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6848-5150 in 1 BOX06/23/2020
10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:0904-6848-4630 in 1 BOX06/23/2020
20.4 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 finalpart34906/23/2020
Labeler - Harvard Drug Group L L C (191427277)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460pack(0904-6848)
Establishment
NameAddressID/FEIBusiness Operations
Unimed689852052manufacture(0904-6848) , label(0904-6848) , pack(0904-6848)

Revised: 7/2020
Document Id: a97ff9b6-e406-089a-e053-2995a90acc99
Set id: a8cbcbee-ecf6-d4b0-e053-2a95a90a56ed
Version: 2
Effective Time: 20200702
 
Harvard Drug Group L L C