RUGBY ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - relieves dryness of the eye - prevents further irritation Directions - instill 1 to 2 drops in the affected eye(s) as needed

Authorization status:

OTC monograph final

Summary of Product characteristics

RUGBY ARTIFICIAL TEARS- POLYVINYL ALCOHOL SOLUTION/ DROPS
NUCARE PHARMACEUTICALS,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._
----------
Active ingredient Purpose
Polyvinyl Alcohol
1.4%...................................................Lubricant
Uses
- relieves dryness of the eye
- prevents further irritation
Do not use
- if solution changes color or becomes cloudy
- with contact lenses
- do not touch tip of container to any surface to avoid contamination
- replace cap after each 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° - 25°C (59° - 77°F)
- keep tightly closed
Inactive ingredients
benzalkonium chloride, dibasic sodium phosphate hydrate, edetate
disodium hydrate, monobasic sodium
phosphate dihydrate, purified water, sodium chloride
Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
www.rugbylaboratories.com
Rugby Laboratories
Made in Korea
RUGBY ARTIFICIAL TEARS
polyvinyl alcohol solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 0 71-4149 (NDC:0 536 -10 8 4)
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 ) (POLYVINYL ALCOHOL -
UNII:532B59 J9 9 0 )
POLYVINYL ALCOHOL 14 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)
SO DIUM PHO SPHATE, DIBASIC, DO DECAHYDRATE (UNII: E1W4N241FO)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
SO DIUM PHO SPHATE, MO NO BASIC, DIHYDRATE (UNII: 5QWK6 6 59 56