BETASEPT- antiseptic surgical scrub solution

BETASEPT by

Drug Labeling and Warnings

BETASEPT by is a Prescription medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

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
• patient preoperative skin preparation: preparation of the patient's skin prior to surgery
• 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, stop use and seek medical help right away.

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
• as a preoperative skin preparation of the head or face

When using this product

• keep out of the eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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 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.

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

Directions

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

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 seperate 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

Healthcare personnel handwash

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

Patient preoperative skin preparation

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

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 information

store at 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

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)

OTHER SAFETY INFORMATION

WARNING: Cancer - www.P65Warnings.ca.gov

PRINCIPAL DISPLAY PANEL

NDC: 67618-200-04

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

Single Use

BETASEPT®

Antiseptic Non-Sterile Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 4 fl oz (118 mL)

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

4BET04BTLLBLG

NDC: 67618-200-08

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 8 fl oz (237 mL)

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

4BET08BTLLBLG

NDC: 67618-200-16

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 16 fl oz (473 mL)

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

4BET16BTLLBLB

NDC: 67618-200-30

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 32 fl oz (946 mL)

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

4BET32BTLLBLB

NDC: 67618-200-32

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 32 fl oz (946 mL)

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

4BET32PBTLLBLB

INGREDIENTS AND APPEARANCE

BETASEPT 
antiseptic surgical scrub solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0116-0200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	0.04 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0200-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
2	NDC: 0116-0200-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
3	NDC: 0116-0200-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
4	NDC: 0116-0200-30	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
5	NDC: 0116-0200-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1993
6	NDC: 0116-0200-01	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 - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0200)