NATURES TEARS- natures tears 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-930(NDC:0536-6237)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSE 2910 (3 MPA.S)4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-930-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/29/2011
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 4/2011
Document Id: 785199ea-3bd6-48ea-afd0-e0c4cf39652b
Set id: 785199ea-3bd6-48ea-afd0-e0c4cf39652b
Version: 1
Effective Time: 20110420
 
Rebel Distributors Corp