Label: SOOTHE NIGHT TIME- white petrolatum mineral oil ointment
- NDC Code(s): 24208-313-34
- 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 January 26, 2023
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- Active ingredients
- Purpose
- Uses
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Warnings
When using this product
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- do not touch tip of container to any surface to avoid contamination
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- do not use with contact lenses
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- replace cap after use
Stop use and ask a doctor if
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- you experience eye pain, changes in vision, continued redness or irritation of the eye
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- condition worsens or persists for more than 72 hours
- Keep out of reach of children.
- Directions
- Other information
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INGREDIENTS AND APPEARANCE
SOOTHE NIGHT TIME
white petrolatum mineral oil ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-313 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 200 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 800 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24208-313-34 3.5 g in 1 TUBE; Type 0: Not a Combination Product 11/15/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 11/15/2011 Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-313)