Bactoshield ® CHG 4% Chlorhexidine Gluconate 4% Solution Brush Sponge

Manufacturer
Deb USA, Inc. | Bajaj Medical , LLC | Biomed Packaging Systems, Inc.
Effective date
2020-12-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:01:02

Label at a glance#

ProductBactoshield CHG
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure10 sections

Dosage and administration

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. open package wet hands and forearms to the elbows with warm water clean under nails with nail pick provided. Nails should be maintained with a 1 millimeter free edge wet sponge and squeeze to work up lather scrub thoroughly for 3 minutes, paying particular attention to the nails, cuticles and...

Storage and handling

store between 20-25°C (68-77°F) avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine Gluconate 4% Solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

WARNINGS SECTION

For external use only

Allergy alert

SPL UNCLASSIFIED SECTION

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

  • wheezing/difficulty breathing
  • hives
  • shock
  • rash
  • facial swelling

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

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to chlorhexidine gluconate or any other ingredients in this product.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter or allowed to remain.
  • if contact occurs, rinse with cold water right away
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • open package
  • wet hands and forearms to the elbows with warm water
  • clean under nails with nail pick provided. Nails should be maintained with a 1 millimeter free edge
  • wet sponge and squeeze to work up lather
  • scrub thoroughly for 3 minutes, paying particular attention to the nails, cuticles and interdigital spaces. Use the brush side to clean the nails, cuticles and interdigital spaces between the fingers and the sponge side to scrub the hands and forearms
  • rinse thoroughly with warm water
  • scrub for an additional 3 minutes using the sponge side
  • discard brush-sponge
  • rinse hands and forearms thoroughly and dry with a sterile towel

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocamide DEA, fragrance POFL 147, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions?

OTC - QUESTIONS SECTION

1-866-783-0422 (Monday to Friday 8 AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL - 25 mL Applicator Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bactoshield® CHG 4%

deb med®

NDC 11084-816-10

Chlorhexidine Gluconate 4% Solution
Surgical Hand Scrub

Surgical Scrub
4% CHG
Antimicrobial

REORDER #
1364-PJ

Principal Display Panel - 25 mL Applicator Box
Principal Display Panel - 25 mL Applicator Box

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11084-81611084-816-09, 11084-816-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019822-001BIOSCRUBCHLORHEXIDINE GLUCONATE4%SPONGE / TOPICAL1989-03-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-3184e616aacf4f…
2026-08-18 06:07:402026-07N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-313f01610625f2…
2019-09-15 20:21 UTC2019-09N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019822-001BIOSCRUB4%SPONGE / TOPICAL1989-03-31f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
48ec3789-57c6-4834-8a4b-09ae4cb2eb3800018a89-9260-459b-86d3-c58a9bb899ea2020-12-14WarningsExact identifier
spl id: 48ec3789-57c6-4834-8a4b-09ae4cb2eb38
spl set id: 00018a89-9260-459b-86d3-c58a9bb899ea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.