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BETASEPT

Antiseptic Surgical Scrub · Solution

Over-the-counter NDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
BETASEPT
Generic name
Antiseptic Surgical Scrub
Dosage form
Solution
Route
Topical
Marketing category
NDA · NDA
Labeler
Atlantis Consumer Healthcare, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
10
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Chlorhexidine Gluconate .04 mg/mL 1667684 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Topical
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Cell Wall Integrity [PE] PE All 26 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
019125
Application type
NDA · New Drug Application
Approval date
December 24, 1984
Sponsor
XTTRIUM
Products on application
1
Submissions recorded
28
Products approved under application 019125.
Product Trade name Form Strength Ingredient Status TE Flags
019125-001 DYNA-HEX 4 SOLUTION CHLORHEXIDINE GLUCONATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 019125.
Type No. Action Status Date Review
Supplement 50 Labeling Approved July 24, 2026 Standard
Supplement 48 Manufacturing (CMC) Approved February 3, 2026 N/A
Supplement 45 Manufacturing (CMC) Approved September 29, 2022 N/A
Supplement 44 Labeling Approved September 14, 2017 Standard
Supplement 42 Labeling Approved October 17, 2014 Standard
Supplement 40 Labeling Approved November 9, 2012 Standard
Supplement 34 Labeling Approved May 16, 2005 Standard
Supplement 31 Manufacturing (CMC) Approved October 8, 1999 Standard
Supplement 30 Manufacturing (CMC) Approved September 8, 1999 Standard
Supplement 29 Manufacturing (CMC) Approved September 11, 1998 Standard
Supplement 28 Manufacturing (CMC) Approved June 6, 1996 Standard
Supplement 27 Manufacturing (CMC) Approved May 6, 1996 Standard
Supplement 26 Manufacturing (CMC) Approved April 12, 1996 Standard
Supplement 25 Manufacturing (CMC) Approved February 21, 1996 Standard
Supplement 24 Manufacturing (CMC) Approved February 6, 1996 Standard
Supplement 23 Manufacturing (CMC) Approved February 6, 1996 Standard
Supplement 21 Manufacturing (CMC) Approved August 28, 1995 Standard
Supplement 19 Manufacturing (CMC) Approved May 10, 1995 Standard
Supplement 18 Manufacturing (CMC) Approved May 10, 1995 Standard
Supplement 17 Manufacturing (CMC) Approved November 6, 1992 Standard
Supplement 13 Manufacturing (CMC) Approved March 7, 1991 Standard
Supplement 11 Manufacturing (CMC) Approved January 23, 1990 Standard
Supplement 4 Efficacy Approved December 27, 1989 —
Supplement 10 Manufacturing (CMC) Approved August 14, 1989 Standard
Supplement 6 Manufacturing (CMC) Approved August 25, 1988 Standard
Supplement 1 Manufacturing (CMC) Approved June 9, 1986 Standard
Supplement 3 Manufacturing (CMC) Approved September 4, 1985 Standard
Original application 1 Type 3 - New Dosage Form Approved December 24, 1984 Standard

Review documents

  • 0 · Supplement · July 28, 2026
  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · October 5, 2022
  • 0 · Supplement · September 30, 2022
  • 0 · Supplement · September 21, 2017
  • 0 · Supplement · September 19, 2017
  • 0 · Supplement · October 30, 2014
  • 0 · Supplement · October 22, 2014
  • 0 · Supplement · November 13, 2012
  • 0 · Supplement · May 18, 2005
  • 0 · Supplement · September 11, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251224). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251224 HUMAN PRESCRIPTION DRUG · 20250430

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Antiseptic

Dosage and Administration

openFDA Drug Labeling

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

Dosage Forms and Strengths

openFDA Drug Labeling

Skin wound and general skin cleansing: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover theskin or wound area and wash gently rinse again thoroughly

Warnings

openFDA Drug Labeling

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

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

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

Stop Use

openFDA Drug Labeling

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

Description

openFDA Drug Labeling

Drug Facts Active ingredient Purpose Chlorhexidine gluconate 4% solution

Active Ingredient

openFDA Drug Labeling

Active ingredient Chlorhexidine gluconate 4% solution

Adverse event reports

Source: openFDA FAERS
9,457
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CHLORHEXIDINE GLUCONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
67618-200-04 67618-200 Atlantis Consumer Healthcare, Inc. 118 mL in 1 BOTTLE (67618-200-04) June 1, 1993
67618-200-08 67618-200 Atlantis Consumer Healthcare, Inc. 237 mL in 1 BOTTLE (67618-200-08) June 1, 1993
67618-200-16 67618-200 Atlantis Consumer Healthcare, Inc. 473 mL in 1 BOTTLE (67618-200-16) June 1, 1993
67618-200-30 67618-200 Atlantis Consumer Healthcare, Inc. 946 mL in 1 BOTTLE (67618-200-30) June 1, 1993
0116-0200-01 0116-0200 Xttrium Laboratories, Inc. 3785 mL in 1 BOTTLE (0116-0200-01) June 1, 1993
0116-0200-04 0116-0200 Xttrium Laboratories, Inc. 118 mL in 1 BOTTLE (0116-0200-04) June 1, 1993
0116-0200-08 0116-0200 Xttrium Laboratories, Inc. 237 mL in 1 BOTTLE (0116-0200-08) June 1, 1993
0116-0200-16 0116-0200 Xttrium Laboratories, Inc. 473 mL in 1 BOTTLE (0116-0200-16) June 1, 1993
0116-0200-30 0116-0200 Xttrium Laboratories, Inc. 946 mL in 1 BOTTLE (0116-0200-30) June 1, 1993
0116-0200-32 0116-0200 Xttrium Laboratories, Inc. 946 mL in 1 BOTTLE (0116-0200-32) June 1, 1993
67618-200 67618-200 Atlantis Consumer Healthcare, Inc. — June 1, 1993
0116-0200 0116-0200 Xttrium Laboratories, Inc. — June 1, 1993

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.