BETASEPT- antiseptic surgical scrub solution

BETASEPT by

Drug Labeling and Warnings

BETASEPT by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma LP, Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Drug Facts
Active ingredient Purpose
Chlorhexidine gluconate 4% solution

ACTIVE INGREDIENT

PURPOSE

Purpose
Antiseptic

WHEN USING

Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and
• forearms prior to surgery or patient care
• healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
• skin wound and general skin cleansing

WARNINGS

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.

DO NOT USE

Do not use

• if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
• in contact with meninges
• in the genital area

WHEN USING

When using this product

• keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
• if solution should contact these areas, rinse out promptly and thoroughly with water
• wounds which involve more than the superficial layers of the skin should not be routinely treated
• repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

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

INDICATIONS & USAGE

Surgical hand scrub:

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

DOSAGE & ADMINISTRATION

Healthcare personnel handwash:

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

SPL UNCLASSIFIED SECTION

Patient preoperative skin preparation:

• apply product liberally to surgical site and swab for at least 2 minutes
• dry with a sterile towel
• repeat procedure for an additional 2 minutes and dry with a sterile towel

DOSAGE FORMS & STRENGTHS

Skin wound and general skin cleansing:

• thoroughly rinse the area to be cleaned with water
• apply the minimum amount of product necessary to cover the skin or wound area and wash gently
• rinse again thoroughly

OTHER SAFETY INFORMATION

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

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

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

304978-0A

PRINCIPAL DISPLAY PANEL

BETASEPT
Antiseptic Surgical Scrub
NDC: 67618–200–30

INGREDIENTS AND APPEARANCE

BETASEPT 
antiseptic surgical scrub solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)	Chlorhexidine Gluconate	.04 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
TRIDECYL ALCOHOL (UNII: 8I9428H868)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
PEG-75 LANOLIN (UNII: 09179OX7TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-200-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
2	NDC: 67618-200-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
3	NDC: 67618-200-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
4	NDC: 67618-200-30	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
5	NDC: 67618-200-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
6	NDC: 67618-200-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	06/01/1993

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	MANUFACTURE(67618-200)