HEB LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops

HEB Lubricant Eye Drops by

Drug Labeling and Warnings

HEB Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by HEB, Unimed Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Carboxymethylcellulose sodium 0.5%

PURPOSE

Purpose
Carboxymethylcellulose sodium.............Lubricant

INDICATIONS & USAGE

Uses

• for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
• may be used as a protectant against further irritation

WARNINGS

​Warnings

For external use only.

​ Do not use this product if

• solution changes color or becomes cloudy

When using the 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 reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

DOSAGE & ADMINISTRATION

Directions

• to open, twist and pull tab to remove.
• instill 1 or 2 drops in the affected eye(s) as needed and discard container
• if used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions.

OTHER SAFETY INFORMATION

Other information

• store at 15°-25°C (59°-77°F).
• use only if single-use container is intact
• use before expiration date marked on container.
• RETAIN THIS CARTON FOR FUTURE REFERENCE

INACTIVE INGREDIENT

Inactive ingredients
calcium chloride, magnesium chloride, potassium chloride, purified water, sodium
chloride, and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid
to adjust pH.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEB LUBRICANT EYE DROPS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-100
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-100-01	30 in 1 CARTON	01/11/2019
1		0.4 mL in 1 VIAL, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/11/2019

Labeler - HEB (007924756)

Registrant - Unimed Pharmaceuticals, Inc. (689852052)

Establishment
Name	Address	ID/FEI	Business Operations
Unimed Pharmaceuticals, Inc.		689852052	label(37808-100) , manufacture(37808-100) , pack(37808-100)