Label: 4718 ENEMA, 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 November 29, 2022

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  • Active Ingredient

    Mineral Oil 100%

  • Purpose

    Lubricant Laxative

  • Uses

    • For relief of occasional constipation.
    • This product generally produces bowel movement in 2 to 15 minutes.
  • Warnings

    For rectal use only.

    Do not use

    • Laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.
    • Longer than one week unless directed by a doctor.

    Ask a doctor before use if you have

    • Noticed a sudden change in bowel habits that persists over a period of two weeks.

    Stop use and ask a doctor if

    • You have rectal bleeding or fail to have a bowel movement after use.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Adults and children 12 years old and older: 1 bottle daily.
    • Children from 2 to under 12 years of age: 1/2 bottle once daily.
    • Children under 2 years old: Consult a doctor.
  • Other information

    • Store at room temperature.
  • Questions?

    • 1-888-Dynarex
  • Label

    4718 Enema Box LabelEnema, Mineral Oil, 4718

  • INGREDIENTS AND APPEARANCE
    4718 ENEMA, MINERAL OIL 
    4718 enema, mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-430
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL133 g  in 133 mL
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-430-0148 in 1 CASE02/26/2021
    1NDC:67777-430-021 in 1 BOX
    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 finalpart33402/26/2021
    Labeler - Dynarex (008124539)
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