Label: SOOTHE XP- light mineral oil and mineral oil solution/ drops
- NDC Code(s): 24208-490-15, 24208-490-30, 24208-490-95
- Packager: Bausch & Lomb Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 29, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- •
- do not touch the tip of container to any surface
- •
- replace cap after using
- Directions
- Other information
- Inactive ingredients
- Questions?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SOOTHE XP
light mineral oil and mineral oil solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-490 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:24208-490-15 1 in 1 BOX 08/26/2010 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:24208-490-30 2 in 1 BOX 08/26/2010 2 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:24208-490-95 1 in 1 BOX 08/26/2010 3 2.5 mL in 1 BOTTLE, DROPPER; 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 08/26/2010 Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-490)