Label: E-VAC PLUS- docusate sodium and benzocaine enema 

  • NDC Code(s): 61357-179-01
  • Packager: ZURICH MEDICAL LABS, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each 5cc disposable tube) Purpose
    Docusate Sodium 283mg Stool Softener Enema
    Benzocaine 20mg Topical Analgesic
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  • Uses

    • For the relief of occasional constipation and/or aid in preventing constipation
    • Helps to reduce pain or rectal damage caused by hard stools or by straining during bowel movements
    • usually produces bowel movement in 2 to 15 minutes
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  • Warnings

    Ask a doctor before use if you have

    • appendicitis
    • symptoms of appendicitis (e.g., nausea, vomiting, abdominal pain)
    • bleeding from the rectum
    • undiagnosed bleeding
    • congestive heart failure
    • high blood pressure
    • fecal impaction
    • intestinal obstruction
    • been taking other prescriptions

    Ask a doctor or pharmacist before use if you are taking mineral oils.

    Stop use and ask a doctor if

    • bleeding from the rectum
    • you fail to have a bowel movement after using this product.

    These may indicate a serious condition.

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

    Keep out of reach of children. In case of accidental ingestion or overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    E-VACâ„¢ MINI-ENEMA & E-VACâ„¢ PLUS MINI-ENEMA is to be used as an enema. This is not a suppository. Do not take orally.

    Administering the mini enema

    Twist off and remove tip. Place water or a few drops of the product on the shaft of the tube to lubricate prior to insertion. It is also recommended that one of these lubricants be applied to the anus before inserting the enema. With steady pressure, gently insert the enema into the rectum with care to prevent damage to the rectal wall. Squeeze to empty the contents. Keep the tube squeezed until it is removed from the rectum. After the contents have been emptied, remove the disposable tube and discard. A small amount of liquid may remain in the unit after use.

    Positioning

    • For best results, lay on left side with knees bent.
    • Second position: Kneel, then lower head and chest forward until side of face resting on surface.
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  • Other Information

    • each mini-enema contains: 283mg sodium docusate
    • Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F).
    • Protect from Freezing. [See USP Controlled Room Temperature.]
    • Below 50% relative humidity is optimal.
    • See box and tube crimp for Lot Number and Expiration Date.
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  • Inactive ingredients

    a medicinal soft soap base of Polyethylene Glycol and Glycerin.

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  • PRINCIPAL DISPLAY PANEL - 30 Tube Box

    E-VAC
    Plus

    MINI-ENEMA

    Suavizante de Heces / Evacuante

    zürich
    medical
    labs

    30 x 5cc TUBOS DESECHABLES

    Principal Display Panel - 30 Tube Box
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  • INGREDIENTS AND APPEARANCE
    E-VAC PLUS 
    docusate sodium and benzocaine enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61357-179
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 283 mg  in 5 mL
    BENZOCAINE (BENZOCAINE) BENZOCAINE 20 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOLS  
    GLYCERIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61357-179-01 30 in 1 BOX
    1 5 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    EXPORT ONLY 01/01/2010
    Labeler - ZURICH MEDICAL LABS, LLC (071904097)
    Establishment
    Name Address ID/FEI Business Operations
    ZURICH MEDICAL LABS, LLC 071904097 MANUFACTURE(61357-179)
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