FDA Label for Soothe Xp Preservative Free
View Indications, Usage & Precautions
Soothe Xp Preservative Free Product Label
The following document was submitted to the FDA by the labeler of this product Bausch & Lomb Incorporated. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.