E-VAC PLUS- docusate sodium and benzocaine enema

E-Vac Plus by

Drug Labeling and Warnings

E-Vac Plus by is a Otc medication manufactured, distributed, or labeled by ZURICH MEDICAL LABS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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.

Directions

E-VAC™ MINI-ENEMA & E-VAC™ 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.

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.

Inactive ingredients

a medicinal soft soap base of Polyethylene Glycol and Glycerin.

PRINCIPAL DISPLAY PANEL - 30 Tube Box

E-VAC
Plus

MINI-ENEMA

Suavizante de Heces / Evacuante

zürich
medical
labs

30 x 5cc TUBOS DESECHABLES

INGREDIENTS AND APPEARANCE

E-VAC PLUS 
docusate sodium and benzocaine enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61357-179
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	283 mg  in 5 mL
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
GLYCERIN (UNII: PDC6A3C0OX)

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)