Dermawerx Surgical PrePak

Manufacturer
Patchwerx Labs, Inc.
Effective date
2015-12-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:21:38

Label at a glance#

ProductDermawerx Surgical PrePak
Active ingredientCHLORHEXIDINE GLUCONATE, DIMETHICONE
Label structure4 sections

Label contents#

Full prescribing information#

Chlorhexidine Gluconate Solution, 4%

SPL UNCLASSIFIED SECTION

Drug Facts

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 surgeryskin wound and general skin cleansing
  • skin wound and general skin cleansing

Warnings

WARNINGS SECTION

For external use only.

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

When using this product

  • 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 eardrums.
  • 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 skin

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

DOSAGE & ADMINISTRATION SECTION

  • use with care in premature infants and 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 separate 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 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 cleaning:

  • 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

STORAGE AND HANDLING SECTION

  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Skin Repair Cream (5% Dimethicone)

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • gently cleanse and dry affected area
  • apply liberally to affected area as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine

Silicone Tape

SPL UNCLASSIFIED SECTION

Uses

• To be applied to wounds or scars as a protective silicone barrier.

• As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers.

• As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care

Precautions

• Do not use if you are allergic to silicone

• Keep out of reach of children

Directions for use

• Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours.

Dermawerx Surgical Pre Pak

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Surgical_Pre_pakSurgical_Pre_pak

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN1
259090dimethicone 5 % Topical CreamPSN1
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD1
259090dimethicone 50 MG/ML Topical CreamSCD1
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY1
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY1
259090dimethicone 5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69329-260-012020-01-31C16284748780-19d75b9cf-d004-f424-e053-dadaa90a57ceDermawerx Surgical PrePak

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-1061-08Dermawerx Surgical PrePak237 mL in 1 BOTTLE, PLASTICSOLUTION237 mL4 g in 100mL1
69329-253-02Dermawerx Surgical PrePak118 mL in 1 TUBECREAM118 mL50 mg in 1mL1
69329-260-01Dermawerx Surgical PrePak1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-1061DERMAWERX SURGICAL PREPAK (CHLORHEXIDINE GLUCONATE PRE-SURGICAL KIT) KIT [PATCHWERX LABS, INC.]1Current NDC, Legacy NDC20151210_2687330c-50dc-0339-e054-00144ff88e88.zip
69329-253DERMAWERX SURGICAL PREPAK (CHLORHEXIDINE GLUCONATE PRE-SURGICAL KIT) KIT [PATCHWERX LABS, INC.]1Unmatched20151210_2687330c-50dc-0339-e054-00144ff88e88.zip
69329-260DERMAWERX SURGICAL PREPAK (CHLORHEXIDINE GLUCONATE PRE-SURGICAL KIT) KIT [PATCHWERX LABS, INC.]1Legacy NDC, 3 package rows20151210_2687330c-50dc-0339-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0116-1061-01ML - Milliliter0116-1061686de54d-1009-450f-a002-cfe03c0ba8d512024-08-12
0116-1061-04ML - Milliliter0116-106153384b36-6c9f-4a2b-a900-284cd855e12512014-02-04
0116-1061-08ML - Milliliter0116-10618a01e33d-0dac-457b-a229-8a9208481f1d12018-10-11
0116-1061-16ML - Milliliter0116-1061b699ecf6-b45d-44f3-9c83-ef5f27e9a1af12019-07-02
0116-1061-18ML - Milliliter0116-106152831c21-df1f-4e81-bc3f-861daf1e7ab412024-11-05
0116-1061-32ML - Milliliter0116-1061f80e8392-1369-4b59-8571-80f8798b240112018-11-06
0116-1061-40ML - Milliliter0116-1061e01292b2-e30b-495c-b3e7-15887ceff47d12024-08-12

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69329-26069329-260-01
0116-10610116-1061-08
69329-25369329-253-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.9f6342f7-faa3-4d23-a860-054d04cb8d422025-12-10WarningsExact identifier
ndc (package): 0116-1061-08
ndc (product): 0116-1061
ndc11 (package): 00116106108
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e5e678f-3832-d201-e053-2a91aa0a5ea82025-04-30WarningsExact identifier
ndc (product): 0116-1061
DermacinRx Surgical ComboPakCHLORHEXIDINE GLUCONATE SURGICAL COMBO KITPureTek Corporation7aff8c66-e758-438a-872d-804a35bb372a2024-12-13WarningsExact identifier
ndc (package): 0116-1061-08
ndc11 (package): 00116106108
DermacinRx ClorhexacinMUPIROCIN OINTMENTPureTek Corporation3c8cb9a6-58e5-4e8d-bfdc-1432a1bde6f92024-12-13Warnings, Adverse reactionsExact identifier
ndc (package): 0116-1061-08
ndc11 (package): 00116106108
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e62eb50-ebaa-361e-e053-2991aa0aba6f2018-06-11WarningsExact identifier
ndc (product): 0116-1061
2687330c-50dd-0339-e054-00144ff88e882687330c-50dc-0339-e054-00144ff88e882015-12-10WarningsExact identifier
spl id: 2687330c-50dd-0339-e054-00144ff88e88
spl set id: 2687330c-50dc-0339-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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