SOOTHE NIGHT TIME- white petrolatum mineral oil ointment

Soothe Night Time by

Drug Labeling and Warnings

Soothe Night Time by is a Otc medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Purpose

Lubricant

Uses

• relieves dryness of the eye
• prevents further irritation

Warnings

When using this product  

• do not touch tip of container to any surface to avoid contamination
• do not use with contact lenses
• 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

• pull down the lower lid of the affected eye
• apply a small amount (1/4 inch) of ointment to the inside of eyelid
• apply one or more times daily

Other information

• store at 15° - 25°C (59° - 77°F)
• keep tightly closed
• see crimp of tube or carton for Lot Number and Expiration Date
• use before expiration date marked on the carton and tube
• serious side effects associated with use of the product may be reported to the phone number below

 

Questions?

Call: 1-800-553-5340

Package/Label Principal Display Panel

pm [with moon and stars icon]

BAUSCH + LOMB

Soothe®

Lubricant Eye Ointment

• For overnight relieve of severe dry eye
• Preservative Free
•   NIGHT TIME
•   Dry Eye Therapy

NET WT 1/8 OZ (3.5 g)

INGREDIENTS AND APPEARANCE

SOOTHE NIGHT TIME 
white petrolatum mineral oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24208-313
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24208-313-34	3.5 g in 1 TUBE; Type 0: Not a Combination Product	11/15/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/15/2011

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-313)