Indications and uses
healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing
Antiseptic Skin Cleanser
- Manufacturer
- Xttrium Laboratories, Inc.
- Effective date
- 2025-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 01:22:13
Label at a glance#
ProductAntiseptic Skin Cleanser
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure11 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. Healthcare personnel handwash: wet hands with water dispense about 5mL of product into cupped hands and wash in a vigorous manner for about 15 seconds rinse and dry thoroughly Skin wound and normal skin cleansing: thoroughly rinse the area to be cleaned with water apply the minimum amount of ...
Storage and handling
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Contacts and useful links#
Websitewww.p65warnings.gov
www.P65Warnings.gov
www.P65Warnings.govLabel contents#
Full prescribing information#
Active Ingredients
Chlorhexidine Gluconate 4% Solution
Purpose
Antiseptic
Uses
- healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
- skin wound and general skin cleansing
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
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 of 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 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.
Healthcare personnel handwash:
- wet hands with water
- dispense about 5mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
- rinse and dry thoroughly
Skin wound and normal 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?
1-800-587-3721
OTHER SAFETY INFORMATION
Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.gov
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
RECENT MAJOR CHANGES SECTION
Indications and Usage
Dosage and Administration
Directions (12/14)
Uses - surgical hand scrub (12/14)
Package label and principal display panel
Compare to the active ingredient in Hibiclens®
ANTISEPTIC/ANTIMICROBIAL
SKIN CLEANSER
CHLORHEXIDINE GLUCONATE 4% SOLUTION
dye free
for external use only
TAMPER-EVIDENT:
DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING
8 FL OZ (237 mL)
4RA08BTLLBLJ
Compare to the active ingredient in Hibiclens®
ANTISEPTIC/ANTIMICROBIAL
SKIN CLEANSER
CHLORHEXIDINE GLUCONATE 4% SOLUTION
dye free
for external use only
TAMPER-EVIDENT:
DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING
16 FL OZ (473 mL)
4RA16BTLLBLC
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | PSN | 9 |
| 211365 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap | SCD | 9 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | SY | 9 |
| 211365 | chlorhexidine gluconate 4 % Medicated Surgical Scrub | SY | 9 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORHEXIDINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0011822367875 | GTIN-13: 0011822367875 EAN-13: 0011822367875 GTIN-12: 011822367875 UPC-A: 011822367875 GTIN storage (14 digits): 00011822367875 | Rite Aid 16oz single panel.jpg |
| Barcode | EAN-13 | 0011822367882 | GTIN-13: 0011822367882 EAN-13: 0011822367882 GTIN-12: 011822367882 UPC-A: 011822367882 GTIN storage (14 digits): 00011822367882 | Rite Aid 8oz Single Panel Label - blank.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0116-3678-07 | Antiseptic Skin Cleanser | 473 mL in 1 BOTTLE | LIQUID | 473 | 9 | |
| 0116-3678-08 | Antiseptic Skin Cleanser | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 9 |
Products#
Every source-derived product name is available through these pages.
- Antiseptic Skin Cleanser
- Chlorhexidine Gluconate 4%
- LAURAMINE OXIDE
- COCO DIETHANOLAMIDE
- PEG-75 LANOLIN
- HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
- ISOPROPYL ALCOHOL
- WATER
- TRIDECYL ALCOHOL
- GLUCONOLACTONE
- CHLORHEXIDINE GLUCONATE
- CHLORHEXIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0116-3678 | 0116-3678-08, 0116-3678-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LAURAMINE OXIDE | 4F6FC4MI8W | IACT |
| COCO DIETHANOLAMIDE | 92005F972D | IACT |
| PEG-75 LANOLIN | 09179OX7TB | IACT |
| HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) | S38J6RZN16 | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| WATER | 059QF0KO0R | IACT |
| TRIDECYL ALCOHOL | 8I9428H868 | IACT |
| GLUCONOLACTONE | WQ29KQ9POT | IACT |
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019125-001 | DYNA-HEX 4 | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION / TOPICAL | 1984-12-24 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019125-001 | DYNA-HEX 4 | 4% | SOLUTION / TOPICAL | 1984-12-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019125-001 | DYNA-HEX 4 | 4% | SOLUTION / TOPICAL | 1984-12-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019125-001 | EXIDINE | 4% | SOLUTION / TOPICAL | 1984-12-24 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Antiseptic Skin Cleanser | CHLORHEXIDINE GLUCONATE 4% | Xttrium Laboratories, Inc. | 4aa41583-790c-2446-e054-00144ff8d46c | 2025-12-10 | Warnings | 0116-3678-07 0116-3678-08 0116-3678 00116367808 00116367807 459bd1c9-d7a4-8bc9-e063-6394a90a8ecd 4aa41583-790c-2446-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.