Artificial Tears Ointment Drug Facts

Artificial Tears by

Drug Labeling and Warnings

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

Drug Details [pdf]

ARTIFICIAL TEARS- white petrolatum mineral oil ointment 
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.

----------

Artificial Tears Ointment Drug Facts

Active ingredient

Mineral oil 15%
White petrolatum 83%

Purpose

Lubricant

Uses

  • prevents further irritation
  • relieves dryness of the eye

Warnings

When using this product  

  • do not touch tip of container to any surface to avoid contamination

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

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

Other information

  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed
  • replace cap after use
  • see crimp of tube or carton for Lot Number and Expiration Date

 

Inactive ingredient

lanolin oil

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.

Package/Label Principal Display Panel

Carton

NDC: 0536-6550-91

Rugby®

STERILE

Artificial Tears Ointment

Lubricant Ophthalmic Ointment

PRESERVATIVE FREE

Prevents irritation and relieves dryness of the eye

Rugby®

Net Wt. 1/8 oz (3.5 g)

ARTIFICIAL TEARS 
white petrolatum mineral oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-6550
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM830 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-6550-913.5 g in 1 TUBE; Type 0: Not a Combination Product10/07/201112/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/07/201112/31/2019
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019
Document Id: 5ab5b131-0979-42d6-b53b-9117e4d3b4f5
Set id: 71876336-83de-4baa-a82d-4b056b41bbeb
Version: 2
Effective Time: 20190906
 
Rugby Laboratories Inc.