BETASEPT

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

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

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.

20241101

6

Active ingredient Chlorhexidine gluconate 4% solution

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

Purpose Antiseptic

BETASEPT Antiseptic Surgical Scrub GLUCONOLACTONE ISOPROPYL ALCOHOL LAURAMINE OXIDE PEG-75 LANOLIN WATER TRIDECYL ALCOHOL CHLORHEXIDINE GLUCONATE CHLORHEXIDINE COCO DIETHANOLAMIDE

NDA019125

BETASEPT

Antiseptic Surgical Scrub

0116-0200

HUMAN PRESCRIPTION DRUG

TOPICAL

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 4oz 8oz 16oz 32oz

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

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

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

WARNING: Cancer - www.P65Warnings.ca.gov

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

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

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