NATURES TEARS solution/ drops

Natures Tears by

Drug Labeling and Warnings

Natures Tears by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hypromellose

Purpose

Lubricant

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

° relieves dryness of the eye

° prevents further irritation

Warnings

Do not use if solution changes color or becomes cloudy

When using this product:

° do not touch tip of container to any surface to avoid contamination

° replace cap after use

Stop use and ask a doctor if:

° you experience eye pain, changes in vision, continued redness or irritation of the eye

° condition worsens or persists for more than 72 hours

Directions

° instill 1 or 2 drops in the affected eye(s) as needed

Other Information

° store at 15° - 30°C (59° - 85°F)

° keep tightly closed

FOR USE IN THE EYES ONLY

Inactive ingredients

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

potassium chloride, sodium chloride, purified water.

Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Preservative added: benzalkonium chloride 0.01%

Questions of Comments?

Call 1-800-645-2158

9 am - 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number.

Distributed by:

Rugby Laboratories, Inc.

Duluth, GA 30097

Repackaged by:

Rebel Distributors Corp.

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

NATURES TEARS 
natures tears solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-930(NDC: 0536-6237)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSE 2910 (3 MPA.S)	4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-930-15	15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/29/2011

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK