RUGBY ARTIFICIAL TEARS- mineral oil and white petrolatum ointment

Rugby Artificial Tears by

Drug Labeling and Warnings

Rugby Artificial Tears by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                        Purpose

Mineral oil 15%............................................Lubricant

White petrolatum 83%..................................Lubricant

PURPOSE

Uses

• for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
• may be used as a protectant against further irritation

WARNINGS

Warnings

For external use only

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using

ASK DOCTOR

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or irritation of the eye
• the condition worsens or persists more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

INDICATIONS & USAGE

Directions

• pull down the lower lid of the affected eye and apply a small amount (1/4") of ointment to the inside of eyelid

STORAGE AND HANDLING

Other information

• store away from heat
• protect from freezing
• use before expiration date marked on container
• store at 59°-86°F (15°-30°C)

INACTIVE INGREDIENT

Inactive ingredient

lanolin alcohol

DOSAGE & ADMINISTRATION

Distributed by:

Rugby Laboratories

17177 N Laurel Park Dr.

Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGBY ARTIFICIAL TEARS 
mineral oil and white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1086
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	830 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1086-91	1 in 1 CARTON	11/08/2016
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/10/2015

Labeler - Rugby Laboratories, Inc. (079246066)