Label: MINERAL OIL oil
- NDC Code(s): 63868-938-16
- Packager: QUALITY CHOICE (Chain Drug Marketing Association)
- 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 November 4, 2022
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- Active ingredient
- Purpose
- Uses
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Warnings
Do not use
- if you have difficulty swallowing
- in children under 12 years of age
- if you are pregnant
- for a period longer than 1 week
- if you are bedridden or aged
Ask a doctor before use if you have
- stomach reflux
- abdominal pain, nausea, or vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
- Package Label
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INGREDIENTS AND APPEARANCE
MINERAL OIL
mineral oil oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-938 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 100 mg in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-938-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2014 05/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/31/2014 05/30/2025 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)