Label: SOOTHE XP- light mineral oil and mineral oil solution/ drops
- NDC Code(s): 24208-490-15
- Packager: Baush & Lomb Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
Light mineral oil (1.0%)
Mineral oil (4.5%)Close
- 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
For external use only.
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.
- remove contact lenses before use
- shake well before using
- 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
edetate disodium, octoxynol-40, polyhexamethylene biguanide (preservative), polysorbate-80, purified water, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), sodium phosphate dibasic, sodium phosphate monobasic.Close
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- Package/Label Principal Display Panel
DRY EYE THERAPY
- Moisturizes for fast relief
- Protects against tear loss
UP TO 8 HOURS OF RELIEF
Restores the lipid layer of tears
Ordinary lubricant eye drops simply provide moisture which can evaporate quickly from the eye’s surface.
- Provides moisture for fast relief AND
- Protects against tear loss for up to8 hours of comfort and relief becauseit contains Restoryl®, the advancedlipid restorative
Expect temporarily blurred vision upon application, as Soothe®XP eye drops seal in moisture.
Bausch & Lomb, Soothe and Restoryl are registered trademarks of Bausch & Lomb Incorporated.
US Patent #5,578,586
© Bausch & Lomb Incorporated
Rochester, NY 14609 Order No. AB49011
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED “Protective Seal” NECKBAND
WITH YELLOW "Mortar and Pestle Symbol" IS NOT INTACT.Close
- INGREDIENTS AND APPEARANCE
light mineral oil and mineral oil solution/ drops
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24208-490 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGHT MINERAL OIL (LIGHT MINERAL OIL) LIGHT MINERAL OIL 0.15 mL in 15 mL MINERAL OIL (MINERAL OIL) MINERAL OIL 0.675 mL in 15 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM OCTOXYNOL-40 POLYAMINOPROPYL BIGUANIDE POLYSORBATE 80 WATER SODIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID SODIUM PHOSPHATE, DIBASIC SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24208-490-15 1 in 1 BOX 1 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 08/26/2010 Labeler - Baush & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE