BETASEPT- antiseptic surgical scrub solution 
Xttrium Laboratories, Inc.

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BETASEPT Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

Warnings

Warnings

For external use only

Allergy alert:

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

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

Do not use

When using this product

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

Surgical hand scrub

Healthcare personnel handwash

Patient preoperative skin preparation

Skin wound and general skin cleansing

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)

WARNING: Cancer - www.P65Warnings.ca.gov

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

BET04 PDP

BET04 DF1

BET04 DF2

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

BET08 PDP

BET08 DF1

BET08 DF2

BET08 DF3

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

BET16 PDP

BET16 DF1

BET16 DF2

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

BET32

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

BET32 w Pump

BETASEPT 
antiseptic surgical scrub solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0116-0200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.04 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-0200-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
2NDC:0116-0200-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
3NDC:0116-0200-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
4NDC:0116-0200-30946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
5NDC:0116-0200-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
6NDC:0116-0200-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912506/01/1993
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-0200)

Revised: 10/2020
Document Id: b17c8d6c-9d57-ab28-e053-2a95a90a9453
Set id: 4a6451d7-b347-37ac-e054-00144ff8d46c
Version: 5
Effective Time: 20201012
 
Xttrium Laboratories, Inc.