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Name:Natures Tears
Manufacturer:Rebel Distributors Corp
Category:Over-the-counter (OTC) Marketed Drugs


Nature's Tears Drug Facts

NATURES TEARS - hypromellose 2910 (3 mpa.s) solution/ drops 
Rebel Distributors Corp

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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Nature's Tears Drug Facts

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

Nature's Tears 0.4%


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPROMELLOSE 2910 (3 MPA.S) (HYPROMELLOSES) HYPROMELLOSE 2910 (3 MPA.S) 4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC  
EDETATE DISODIUM  
SODIUM PHOSPHATE, MONOBASIC  
POTASSIUM CHLORIDE  
SODIUM CHLORIDE  
WATER  
BENZALKONIUM CHLORIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-930-15 15 mL in 1 BOTTLE None

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 Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 04/2011 Rebel Distributors Corp



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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