Your browser does not support JavaScript! NATURES TEARS (HYPROMELLOSE) SOLUTION/ DROPS [RUGBY LABORATORIES INC.]
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NATURES TEARS (hypromellose) solution/ drops
[Rugby Laboratories Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 DRUG LABELItem Code (Source)NDC:0536-6237
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE 2910 (3 MPA.S) (HYPROMELLOSES) HYPROMELLOSE 2910 (3 MPA.S)4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC 
EDETATE DISODIUM 
SODIUM PHOSPHATE, MONOBASIC 
POTASSIUM CHLORIDE 
SODIUM CHLORIDE 
WATER 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-6237-7215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/07/2011
Labeler - Rugby Laboratories Inc. (109178264)
Registrant - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated196603781MANUFACTURE

Revised: 11/2011
 
Rugby Laboratories Inc.

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