Betasept Antiseptic Surgical Scrub

Betasept Antiseptic Surgical Scrub
SPL v13
SPL
SPL Set ID 7e64e7bf-e88f-4056-c9e1-b49a277daa6c
Route
TOPICAL
Published
Effective Date 2018-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (.04 mg)
Inactive Ingredients
Coco Diethanolamide Hydroxyethyl Cellulose (2000 Cps At 1%) Isopropyl Alcohol Lauramine Oxide Water Tridecyl Alcohol Gluconolactone Peg-75 Lanolin

Identifiers & Packaging

Marketing Status
NDA Active Since 1993-06-01 Until 2018-05-31

Description

Drug Facts Active ingredient Purpose Chlorhexidine gluconate 4% solution


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • Shock
  • facial swelling
  • hives
  • rash. 

If an allergic reaction occurs, stop use and seek medical help right away.

Indications and Usage

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product and a wetbrush, paying close attention to the nails, cuticles, and interdigitalspaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product andrinse under running water
  • dry thoroughly
Dosage and Administration

Healthcare personnelhandwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and washin a vigorous manner for 15 seconds
  • rinse and dry thoroughly
Description

Drug Facts

Active ingredient Purpose

Chlorhexidine gluconate 4% solution

Section 43678-2

Skin wound and general skin cleansing:

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover theskin or wound area and wash gently
  • rinse again thoroughly
Section 50565-1

Keep out of reach of children. Ifswallowed, get medical help or contact a Poison Control Center rightaway.

Section 50566-9

Stop use and ask a doctor if irritation,sensitization, or allergic reaction occurs. These may be signs ofa serious condition.

Section 50567-7

Uses

  • surgical hand scrub: significantly reducesthe number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reducebacteria that potentially can cause disease
  • skin wound and general skin cleansing
Section 50570-1

Do not use

  • if you or the patient is allergic to chlorhexidine gluconateor any other ingredient in this product
  • in contact with meninges
  • in the genital area
Section 51727-6

Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions or comments? call 1-888-827-0624 (8am-5pm, EST, Mon-Fri.)

WARNING: This product can expose you to chemicals including coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Dist. by: Avrio Health L.P. Stamford, CT 06901-3431

304978-0A

Section 51945-4

BETASEPT

Antiseptic Surgical Scrub

NDC: 67618–200–30

Section 55105-1

Purpose

Antiseptic

Section 60561-8

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Structured Label Content

Indications and Usage (34067-9)

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product and a wetbrush, paying close attention to the nails, cuticles, and interdigitalspaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product andrinse under running water
  • dry thoroughly
Dosage and Administration (34068-7)

Healthcare personnelhandwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and washin a vigorous manner for 15 seconds
  • rinse and dry thoroughly
Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • Shock
  • facial swelling
  • hives
  • rash. 

If an allergic reaction occurs, stop use and seek medical help right away.

Description (34089-3)

Drug Facts

Active ingredient Purpose

Chlorhexidine gluconate 4% solution

Section 43678-2 (43678-2)

Skin wound and general skin cleansing:

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover theskin or wound area and wash gently
  • rinse again thoroughly
Section 50565-1 (50565-1)

Keep out of reach of children. Ifswallowed, get medical help or contact a Poison Control Center rightaway.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation,sensitization, or allergic reaction occurs. These may be signs ofa serious condition.

Section 50567-7 (50567-7)

Uses

  • surgical hand scrub: significantly reducesthe number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reducebacteria that potentially can cause disease
  • skin wound and general skin cleansing
Section 50570-1 (50570-1)

Do not use

  • if you or the patient is allergic to chlorhexidine gluconateor any other ingredient in this product
  • in contact with meninges
  • in the genital area
Section 51727-6 (51727-6)

Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions or comments? call 1-888-827-0624 (8am-5pm, EST, Mon-Fri.)

WARNING: This product can expose you to chemicals including coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Dist. by: Avrio Health L.P. Stamford, CT 06901-3431

304978-0A

Section 51945-4 (51945-4)

BETASEPT

Antiseptic Surgical Scrub

NDC: 67618–200–30

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 60561-8 (60561-8)

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)