Label: EQUATE RESTORE PM NIGHTTIME LUBRICANT EYE- mineral oil and petrolatum ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-191-50 - Packager: Wal-Mart Stores, Inc.
- 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 19, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
• For use in the eyes only. • Save box for complete information.
When using this product
• avoid contamination, do not touch tip of container to any surface.
• replace cap after use.
- Directions
- Other Information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUATE RESTORE PM NIGHTTIME LUBRICANT EYE
mineral oil and petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-191 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 425 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 573 mg in 1 g Inactive Ingredients Ingredient Name Strength LANOLIN ALCOHOLS (UNII: 884C3FA9HE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-191-50 1 in 1 BOX 03/14/2013 1 3.5 g in 1 TUBE; 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 03/14/2013 Labeler - Wal-Mart Stores, Inc. (051957769) Registrant - Altaire Pharmaceuticals, Inc. (786790378)