Label: ENEMA MINERAL OIL- mineral oil enema

  • 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 16, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 120 ml delivered dose)

    Mineral oil 100%

  • Purpose

    Lubricant laxative

  • Use

    • for relief of occasional constipation
    • this product generally produces bowel movement in 2 to 15 minutes
  • Warnings

    For rectal use only.

    Caution

    To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.

    Do not use

    • on children under 13 years of age
    • on pregnant women
    • on persons with difficulty swallowing
    • on bedridden patients
    • if you are presently taking a stool softener laxative
    • or take with meals

    Ask a doctor before use if you

    • have already used a laxative for more than 3 days
    • have abdominal pain, nausea, or vomiting
    • have a sudden change in bowel habits that persist over a period of 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you have no bowel movement within 30 minutes of enema use

    As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.

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

  • Directions (or as directed by a doctor)

    Rectal enema dosage is 120 ml in a single daily dosage (per 24 hours).

    Adults & children 13 years old and older1 bottle
    Children under 13 years oldDO NOT USE
  • Other information

    • Store at 15 to 30°C (59 to 86°F).
    • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
  • Inactive ingredient

    None

  • Questions or comments?

    1-866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    *Compare To Fleet® Mineral Oil Enema

    Natureplex™

    READY TO USE

    Enema

    Mineral
    Oil

    Sodium
    Free

    For
    Relief Of
    Occasional
    Constipation

    Not Made
    With
    Natural
    Rubber
    Latex

    Soft,
    Easy To
    Use
    Bottle

    NDC 67234-019-01

    1
    Bottle
    4.5 Fl Oz
    (133 mL)

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ENEMA MINERAL OIL 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-019
    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:67234-019-011 in 1 CARTON01/05/2013
    1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/05/2013
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-019)
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