Aplicare Chlorhexidine Gluconate 2% Solution

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2019-11-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-02 00:02:55

Label at a glance#

ProductAplicare Chlorhexidine Gluconate 2% Solution
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure10 sections

Indications and uses

surgical hand scrub : si8gnificantly 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 general skin cleansing

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Chlorhexidine Gluconate 2% solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • surgical hand scrub: si8gnificantly 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 general skin cleansing

WARNINGS SECTION

Warnings



For external use only

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face

OTC - WHEN USING SECTION

When using this product

  • single use when used for patient preoperative skin preparation
  • 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 ear drums
  • 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 the underlying condition makes it necessary to reduce the bacterial population 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.

DOSAGE & ADMINISTRATION SECTION

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 under running water for 30 seconds. Clean fingernails using a nail stick or similar cleaner.
  • scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles and skin between the fingers.
  • rinse thoroughly under running water for 30 seconds
  • wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
  • dry thoroughly

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

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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

OTC - QUESTIONS SECTION

Questions or comments?

1-800-760-3236 (Mon.-Fri. 8:30AM - 5:00 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aplicare

CHLORHEXIDINE GLUCONATE 2% SOLUTION

ANTISEPTIC

L919-0914L919-0914

Products#

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DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-19190116-1919-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
N019422-001DYNA-HEX 2CHLORHEXIDINE GLUCONATE2%SOLUTION / TOPICALRLD, RS1985-12-17

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 22:38:342026-08N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-1784e616aacf4f…
2026-08-18 06:07:402026-07N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17f41ea6bd6efb…

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96a05aec-a46a-5e1e-e053-2995a90ab3614ab61c3d-dfe9-49c8-e054-00144ff8d46c2019-11-05WarningsExact identifier
spl id: 96a05aec-a46a-5e1e-e053-2995a90ab361
spl set id: 4ab61c3d-dfe9-49c8-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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