Label: LEADER MINERAL OIL- mineral oil liquid
- NDC Code(s): 70000-0448-1
- Packager: Cardinal Health, 110 dba Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 17, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER MINERAL OIL
mineral oil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0448 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 1000 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0448-1 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/18/2018 Labeler - Cardinal Health, 110 dba Leader (063997360) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 analysis(70000-0448) , manufacture(70000-0448) , pack(70000-0448) , label(70000-0448)