Label: MINERAL OIL HEAVY- mineral oil liquid
- NDC Code(s): 0395-9135-16, 0395-9135-32
- Packager: Humco Holding Group, Inc.
- 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.
Updated June 23, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.
Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.
- Ask a doctor before use if
- When using this Product discotinue use
- Keep out of reach of children
- Inactive ingredient
- Other information
- CVS Label
- Leader Label
INGREDIENTS AND APPEARANCE
MINERAL OIL HEAVY
mineral oil liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9135 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:0395-9135-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/18/2018 2 NDC:0395-9135-32 950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/18/2018 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 manufacture(0395-9135) , analysis(0395-9135) , pack(0395-9135) , label(0395-9135)