TEARS AGAIN OPHT- mineral oil, white petrolatum ointment

Tears Again by

Drug Labeling and Warnings

Tears Again by is a Otc medication manufactured, distributed, or labeled by OCuSOFT, Inc., Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Mineral oil (20%)
White Petrolatum (80%)

OTC - PURPOSE SECTION

Eye lubricant

INDICATIONS & USAGE SECTION

A lubricant to prevent further irritation or to relieve dryness of the eye(s).

WARNINGS SECTION

For use in the eyes only.

OTC - WHEN USING SECTION

When using this product
■ do not touch tip of container to any surface to avoid contamination.
■ replace cap after use.  

OTC - ASK DOCTOR SECTION

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 for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.  

DOSAGE & ADMINISTRATION SECTION

Directions
■ Pull down the lower lid of the affected eye(s).
■ Apply a small amount (1/4) inch) of ointment t the inside of the eyelid.

OTHER SAFETY INFORMATION

Other information
■ Do not use if cap breakaway seal is broken or missing.
■ Store between 15° -30°C (59° -86°F).
■ Keep this carton for full product information.

OTC - QUESTIONS SECTION

Questions?
☏ Call
(800)233-5469 M-F
8:30AM-5:00PM CST
or visit www.ocusoft.com

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEARS AGAIN   OPHT
mineral oil, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54799-906
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	200 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	800 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-906-35	5 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2013

Labeler - OCuSOFT, Inc. (174939207)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	manufacture(54799-906)