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Home > Drugs > Antiseptic and germicides > Betasept > Betasept Antiseptic Surgical Scrub Prescribing Information
Antiseptic and germicides
https://themeditary.com/pro/betasept-antiseptic-surgical-scrub-prescribing-information-13128.html

Betasept Antiseptic Surgical Scrub Prescribing Information

Drug Detail:Betasept (Chlorhexidine topical [ klor-hex-i-deen-top-i-kal ])

Drug Class: Antiseptic and germicides Mouth and throat products

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Betasept Antiseptic Surgical Scrub Description

Drug Facts
Active ingredient Purpose
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
  • 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.

Related/similar drugs

chlorhexidine topical, Hibiclens, Tegaderm CHG Dressing, ChloraPrep One-Step, hexachlorophene topical

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 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 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.

Indications and Usage for Betasept Antiseptic Surgical Scrub

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

Betasept Antiseptic Surgical Scrub Dosage and 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

Dosage Forms and 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 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: This product can expose you to chemicals including coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

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

304978-0A

BETASEPT
Antiseptic Surgical Scrub
NDC: 67618–200–30

304978-0A
BETASEPT
antiseptic surgical scrub solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate.04 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-200-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
2NDC:67618-200-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
3NDC:67618-200-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
4NDC:67618-200-30946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1993
5NDC:67618-200-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/199301/31/2023
6NDC:67618-200-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/199305/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912506/01/1993
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579MANUFACTURE(67618-200)

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