SOOTHE LONG LASTING- povidone solution
Bausch & Lomb Incorporated

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.

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Drug Facts

Active ingredient

Povidone (2.0%)

Purpose

Lubricant

Uses

■ relieves dryness of the eye

■ prevents further irritation

Warnings

For external use only.

Do not use

■ if solution changes color or becomes cloudy

When using this product

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

■ remove contact lenses before using

■ replace cap after using

Stop use and ask a doctor if you experience

■ eye pain

■ change in vision

■ continued redness or irritation of the eye

■ or if condition worsens or lasts more than 72 hours

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control

Center right away.

Directions

■ Instill 1 or 2 drop(s) in the affected eye(s) as needed or as

directed by your doctor

Other information

■ Storage: 15°-25°C (59°-77°F)

■ Use before expiration date marked on the carton or bottle

Inactive ingredients

Benzalkonium chloride (0.005%), boric acid, edetate

disodium dihydrate, purified water, sodium borate, sodium

chloride, tyloxapol. Hydrochloric acid and/or

sodium hydroxide may be used to adjust pH.

Questions?

Call:1-800-553-5340

Package/Label Principal Display Panel

Bausch & Lomb

Soothe

Lubricant Eye Drops

LONG LASTING

Dry Eye Therapy

• Instant and Long Lasting Relief

• Moisturizes and Protects

• For All Types of Dry Eye

Sterile

0.5 FL OZ (15mL)

SOOTHE LONG LASTING
povidone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24208-544
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TYLOXAPOL (UNII: Y27PUL9H56)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24208-544-01	1 in 1 CARTON	06/01/2013	07/01/2013
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	06/01/2013	07/01/2013

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-544)

Revised: 12/2017

Document Id: c6463480-cd30-4020-ab7b-d7e361997930

Set id: 30a388e9-b7e7-400d-8574-baf60a59375f

Version: 3

Effective Time: 20171220

Bausch & Lomb Incorporated