SOOTHE XP PRESERVATIVE FREE- light mineral oil and mineral oil solution/ drops

Soothe XP Preservative Free by

Drug Labeling and Warnings

Soothe XP Preservative Free by is a Otc medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated, Laboratoire Unither. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Light mineral oil (1.0%)

Mineral oil (4.5%)

Purpose

Emollient

Emollient

Uses

• temporary relief of burning and irritation due to dryness of the eye
• temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
• as a protectant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Do not use

• if solution changes color
• if single-unit dispenser is not intact

When using this product

• do not touch the tip of container to any surface to avoid contamination
• once opened, discard
• do not reuse

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or irritation of the eye, or if 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

• remove contact lenses before use
• shake well before using
• to open, completely twist off tab
• instill 1 or 2 drop(s) in the affected eye(s) as needed or as directed by your doctor

Other information

• temporarily blurred vision is typical upon application
• drops appear as a milky white solution
• store at 15°-25°C (59°-77°F)

Inactive ingredients

boric acid, edetate disodium, octoxynol-40, polysorbate 80, purified water, sodium borate decahydrate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions?

Call: 1-800-553-5340

Package/Label Principal Display Panel

NEW

BAUSCH + LOMB

Soothe® XP

Emollient (Lubricant) Eye Drops

Preservative Free

XTRA PROTECTION

Advanced Dry Eye Therapy

With Restoryl® a unique combination

of mineral oils that:

Moisturizes for fast relief

Protects against tear loss

Restores the lipid layer of tears

Gentle enough for sensitive eyes

•  
  • FL OZ EA (0.3 mL EA)

Sterile

30 Single-Use Dispensers

INGREDIENTS AND APPEARANCE

SOOTHE XP PRESERVATIVE FREE 
light mineral oil and mineral oil solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24208-742
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP)	LIGHT MINERAL OIL	10 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OCTOXYNOL-40 (UNII: 9T1C662FKS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24208-742-01	30 in 1 CARTON	04/18/2018
1		0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 24208-742-99	5 in 1 POUCH	08/22/2018
2		0.3 mL in 1 VIAL, SINGLE-USE; 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	04/18/2018

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoire Unither		574139809	MANUFACTURE(24208-742)

Establishment
Name	Address	ID/FEI	Business Operations
Calumet Karns City Refining LLC		114222776	API MANUFACTURE(24208-742)