Label: MINERAL OIL liquid
- NDC Code(s): 63868-831-43
- Packager: C.D.M.A.
- Category: HUMAN OTC DRUG LABEL
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 March 14, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Active ingredient
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor
- If breast feeding
- Keep out of reach of children.
- do not take with meals
- take only at bedtime
- may be taken as a single daily dose or in divided doses
adults and children 12 years of age and over - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours
children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours
children under 6 years of age - do not use, consult a doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
INGREDIENTS AND APPEARANCE
mineral oil liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-831 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 99.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-831-43 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/22/2019 Labeler - C.D.M.A. (011920774) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63868-831) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63868-831)