Label: MINERAL OIL oil

  • NDC Code(s): 36800-334-16
  • Packager: TOP CARE (Topco Associates LLC)
  • 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 December 19, 2022

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  • Active Ingredient

    Mineral Oil 100%

  • Purpose

    Lubricant laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 8 hours
  • Warnings

    Do not use

    • in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
    • if you are presently taking a stool softener laxative
    • for longer than 1 week

    Ask a doctor before use if you have

    • abdominal pain, nausea or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks

    When using this product

    • do not take with meals
    • take only at bedtime

    Stop use and ask a doctor if you have

    rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

    If pregnant or breast feeding,

    ask a health professional before use

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

  • Directions

    • 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 to 45 mL)
      • maximum 3 tablespoons (45 mL) in 24 hours
    • children under 12 years, consult a doctor 
  • Other Information

    • keep tightly closed
    • protect from direct light
  • Inactive Ingredient

    Vitamin E as stabilizer

  • Principal Display Panel

    Mineral Oil

    LUBRICANT LAXATIVE

    • For Relief of Occasional Constipation
    • Odorless
    • Tasteless
    • Colorless

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topco.com

    www.topcarebrand.com

    Questions or comments? Call toll free 1-888-423-0139

  • Package Label

    Mineral Oil 100%

    TOPCARE HEALTH Mineral Oil

     

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-334
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-334-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/30/2016
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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