Label: HEALTHMART MINERAL OIL SINGLE LAXATIVE- mineral oil enema

  • NDC Code(s): 62011-0270-1
  • Packager: Strategic Sourcing Services 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 January 21, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 118 mL delivered dose)

    Mineral Oil 100%

  • Purpose

    Lubricant laxative

  • Use

    • for relief of occasional constipation
  • Warnings

    For rectal use only.

    Ask a doctor before use if you have

    • abdominal pain, nausea, or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week

    Stop use and ask a doctor if you have:

    • rectal bleeding
    • no bowel movement after use

    These symptoms may indicate a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    Single daily dosage

    Do not use more unless directed by a doctor. See Warnings.

    Adults and children 12 years old and over1 bottle
    Children 2 to under 12 years old1/2 bottle once daily
    Children under 2 yearsDO NOT USE
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • this product generally produces a bowel movement in 1-5 minutes
    • carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.
  • Inactive ingredients

    none

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street, San Francisco, CA 94104

  • PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

    NDC 62011-0270-1

    Health Mart®
    PHARMACY

    compare to
    Fleet® Mineral Oil
    active ingredients*

    complete
    ready-to-use
    enema
    mineral oil

    lubricant laxative

    for relief of occasional
    constipation

    lubricated tip
    sodium free
    latex free

    4.5 fl oz (133 ml)
    single pack

    Principal Display Panel - 133 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HEALTHMART MINERAL OIL SINGLE   LAXATIVE
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0270
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL118 g  in 118 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0270-11 in 1 CARTON05/10/2012
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33405/10/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(62011-0270)
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