Label: BETASEPT- antiseptic surgical scrub solution
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NDC Code(s):
0116-0200-01,
0116-0200-04,
0116-0200-08,
0116-0200-16, view more0116-0200-30, 0116-0200-32
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 1, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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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
- Do not use
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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
- Keep out of reach of children.
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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
- Inactive ingredients
- Questions or comments?
- OTHER SAFETY INFORMATION
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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: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA
©2023 Atlantis Consumer Healthcare Inc.
4BET04BTLLBLH
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:Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA
©2023 Atlantis Consumer Healthcare Inc.
4BET08BTLLBLH
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: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA
©2023 Atlantis Consumer Healthcare Inc.
4BET16BTLLBLC
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: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA
©2023 Atlantis Consumer Healthcare Inc.
4BET32PBTLLBLC
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INGREDIENTS AND APPEARANCE
BETASEPT
antiseptic surgical scrub solutionProduct 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 GLUCONOLACTONE (UNII: WQ29KQ9POT) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) PEG-75 LANOLIN (UNII: 09179OX7TB) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) COCO DIETHANOLAMIDE (UNII: 92005F972D) 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)