Label: MINERAL OIL WITH PETROLEUM- mineral oil and white petrolatum ointment
- NDC Code(s): 0536-1383-91
- Packager: Rugby Laboratories
- 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 February 27, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- Stop use
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredient
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL OIL WITH PETROLEUM
mineral oil and white petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1383 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 30 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 940 mg in 1 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1383-91 1 in 1 CARTON 02/27/2023 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 02/27/2023 Labeler - Rugby Laboratories (079246066)