Nature's Tears Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

NATURES TEARS- hypromellose solution/ drops 
Rugby Laboratories Inc.

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 0.4%

Purpose

Lubricant

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

Keep out of reach of children.

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

Directions

  • instill 1 to 2 drops in the affected eye(s) as needed

Other information

  • store at 15° - 30°C (59° - 86°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 or 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.

Rugby ®

Duluth, GA 30097

Package/Label Principal Display Panel

Carton

NDC: 0536-6237-72

Rugby®

COMPARED TO INDICATIONS IN TEARS NATURALE®

Nature's Tears

Hypromellose 0.4%

Lubricant

Eye Drops

STERILE

Rugby®

1/2 fl oz (15 mL)

NATURES TEARS 
hypromellose solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-6237
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) (HYPROMELLOSE 2910 (3 MPA.S) - UNII:0VUT3PMY82) HYPROMELLOSE 2910 (3 MPA.S)4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (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: 0536-6237-7215 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/201103/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/07/201103/31/2019
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019
Document Id: ddbd5c2e-ac3e-4ab5-b8bc-168cb9caa1da
Set id: 3bb70d72-f763-4486-8f6a-d37ece21292b
Version: 2
Effective Time: 20190906