CliniClean

Manufacturer
HR Pharmaceuticals, Inc. | Xttrium Laboratories, Inc. | Xttrium Laboratories, Inc
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:45:58

Label at a glance#

ProductCliniClean
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure10 sections

Indications and 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: for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing

Dosage and administration

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 5mL 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 5mL of product...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 4% solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

Warnings

WARNINGS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with the meninges
  • in the genital area

When using this product

OTC - WHEN USING SECTION

  • keep out of 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 eardurms.
  • 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 healthcare provider

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5mL 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 5mL of product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5mL of product into cupped hands and wash in a vigrous 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
  • 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Laudering/Cleaning Instructions

CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

Display Panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69494-901-04

REF 90104

CliniClean

Chlorhexidine Gluconate 4%

Antispetic/Antimicrobial Solution

Non-Sterile

Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser

For Single-Use

Net Content: 4 fl oz (118mL)

DYE FREE

Manufactured for:

HR Pharmaceuticals, Inc.

York, PA 17402

cliniclean.com

Rev 4170-0 (02/2023)

4HRP04BTLLBL

HRP 4oz FT 1HRP 4oz FT 1

HRP 4oz FT 2HRP 4oz FT 2

HRP 4oz FT 3HRP 4oz FT 3

HRP 4oz FT 4HRP 4oz FT 4

HRP 4oz FT 5HRP 4oz FT 5

NDC 69494-901-15

REF 901515

CliniClean

Chlorhexidine Gluconate 4%

Antispetic/Antimicrobial Solution

Non-Sterile

Patient Pre-Operative Prep, Surgical Hand Scrub, Healthcare Personnel Hand Wash. General Skin & Wound Cleanser

For Single-Use

Net Contents: 50 Single-Use 0.5 fl oz (15 mL) Packettes

DYE FREE

Manufactured for:

HR Pharmaceuticals, Inc.

York, PA 17402

cliniclean.com

Rev 4175-0 (02/2023)

4HRP15INNCTN

HRP 15ml Cart 1HRP 15ml Cart 1

HRP 15ml Cart 2HRP 15ml Cart 2

HRP 15ml Cart 3HRP 15ml Cart 3

HRP 15ml Cart 4HRP 15ml Cart 4

HRP 15ml Cart 5HRP 15ml Cart 5

4HRP15PACKET

HRP 15ml pkt 1HRP 15ml pkt 1

HRP 15ml pkt 2HRP 15ml pkt 2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69464-90169464-901-15, 69464-901-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
N019125-001DYNA-HEX 4CHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICAL1984-12-24

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 22:38:342026-08N019125-001DYNA-HEX 44%SOLUTION / TOPICAL1984-12-2484e616aacf4f…
2026-08-18 06:07:402026-07N019125-001DYNA-HEX 44%SOLUTION / TOPICAL1984-12-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243f01610625f2…
2019-09-15 20:21 UTC2019-09N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50c47b59-543e-4eb1-e063-6394a90aa978f7984baf-99e8-94a2-e053-6294a90ac22d2026-05-01WarningsExact identifier
spl set id: f7984baf-99e8-94a2-e053-6294a90ac22d
CliniCleanCHLORHEXIDINE GLUCONATE 4%HR Pharmaceuticals, Inc.f7959667-6275-802a-e053-6394a90aa7f12025-12-16WarningsExact identifier
ndc (product): 69464-901

Reported adverse events (FAERS/openFDA)#

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