SURGICEPT

Manufacturer: HEALTHPOINT, LTD | DPT LABORATORIES, LTD
Effective date: 2017-09-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:52:29

Label at a glance#

ProductSURGICEPT Waterless, Surgical Handscrub and Healthcare Personnel Handwash

Active ingredientALCOHOL

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: Handwash to help reduce bacteria that potentially can cause disease. Recommended for repeated use.

Contacts and useful links#

PhoneLabel contact1-800-523-0502

Websitewww.surgicept.com

www.surgicept.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% w/w

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: Handwash to help reduce bacteria that potentially can cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame.
For external use only.
Do not use
- if you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product.
- on or near the eyes, mucous membranes or mouth. If product gets into the eyes, flush immediately with water.
Stop use and ask a doctor if irritation, redness or allergic reaction occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Surgical Hand Scrub: Clean under nails with a nail pick. Nails should be maintained with a 1mm free edge. Apply to clean, dry hands. (1) Dispense sufficient quantity of SURGICEPT to cover one hand (approx. 2ml) into cupped palm. Dip the fingertips of your opposite hand into SURGICEPT and work under the nails. Spread remainder of SURGICEPT on hand and lower two-thirds of forearm. (2) Repeat Step 1 with other hand and forearm. (3) Dispense an additional sufficient quantity (approx. 2ml) of SURGICEPT and apply to all surfaces of hands up to wrists, paying particular attention to nails, cuticles, and interdigital spaces. Allow to dry before donning gloves. Do not dry with a towel.
Healthcare Personnel Handwash: Wet hands thoroughly with SURGICEPT and allow to dry without wiping.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Other information

Store upright at 20-25°C (68-77°F)
Avoid freezing and excessive heat.
Protect from light until use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Behentrimonium methosulfate, benzalkonium chloride, butylene glycol, cetyl alcohol, chlorhexidine gluconate, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polyquaternium-10, PPG-3 myristyl ether, water.

Questions?

OTC - QUESTIONS SECTION

Please call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) or visit our web site www.surgicept.com.

PRINCIPAL DISPLAY PANEL

NDC 0064-1080-59

Surgicept ^®

Ethyl alcohol 70% w/w

WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash

2 fl oz (59 ml)
129464-1010

Marketed by:
CareFusion, Leawood, KS 66211

Manufactured for:
Healthpoint, Ltd., Fort Worth, TX 76107
by DPT Laboratories, Ltd., San Antonio, TX 78215

REORDER NO. 0064-1080-59
PATENT NO. 6,846,846

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0064-1080-11	2022-01-28	C162847	48780-1	d6a99b39-d01b-a426-e053-dadaa90af4c2	SURGICEPT WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash – alcohol solution CareFusion
0064-1080-59	2022-01-28	C162847	48780-1	d6a99b39-d01b-a426-e053-dadaa90af4c2	SURGICEPT WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash – alcohol solution CareFusion
0064-1080-80	2022-01-28	C162847	48780-1	d6a99b39-d01b-a426-e053-dadaa90af4c2	SURGICEPT WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash – alcohol solution CareFusion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0064-1080-11	SURGICEPTWaterless, Surgical Handscrub and Healthcare Personnel Handwash	1150 mL in 1 BOTTLE, DISPENSING	SOLUTION	1150	4
0064-1080-59	SURGICEPTWaterless, Surgical Handscrub and Healthcare Personnel Handwash	59 mL in 1 BOTTLE	SOLUTION	59	4
0064-1080-80	SURGICEPTWaterless, Surgical Handscrub and Healthcare Personnel Handwash	800 mL in 1 BAG	SOLUTION	800	4
0064-1080-80	SURGICEPTWaterless, Surgical Handscrub and Healthcare Personnel Handwash	1 in 1 CARTON	SOLUTION	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0064-1080	SURGICEPT WATERLESS, SURGICAL HANDSCRUB AND HEALTHCARE PERSONNEL HANDWASH (ETHYL ALCOHOL) SOLUTION [HEALTHPOINT, LTD]	4	Legacy NDC, 4 package rows	20170912_96fe2cc7-e812-4d39-8f11-bd3cc7411a21.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	3
ALCOHOL	ACTIVE MOIETY	3K9958V90M	3
BEHENTRIMONIUM METHOSULFATE	INACTIVE INGREDIENT	5SHP745C61	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	3
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
CHLORHEXIDINE GLUCONATE	INACTIVE INGREDIENT	MOR84MUD8E	3
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3
POLYQUATERNIUM-10 (400 CPS AT 2%)	INACTIVE INGREDIENT	HB1401PQFS	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

SURGICEPT Waterless, Surgical Handscrub and Healthcare Personnel Handwash
ethyl alcohol
BEHENTRIMONIUM METHOSULFATE
BENZALKONIUM CHLORIDE
BUTYLENE GLYCOL
CETYL ALCOHOL
CHLORHEXIDINE GLUCONATE
ETHYLHEXYLGLYCERIN
ISOPROPYL ALCOHOL
PHENOXYETHANOL
POLYQUATERNIUM-10 (400 CPS AT 2%)
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0064-1080	0064-1080-59, 0064-1080-11, 0064-1080-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BEHENTRIMONIUM METHOSULFATE	5SHP745C61	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYQUATERNIUM-10 (400 CPS AT 2%)	HB1401PQFS	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 61 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / AURICULAR (OTIC)		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / NASAL	40.46 mg/100ml		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
58f2bf97-8743-5857-e053-2a91aa0a13ff			96fe2cc7-e812-4d39-8f11-bd3cc7411a21	2017-09-11	Warnings	Exact identifier spl id: 58f2bf97-8743-5857-e053-2a91aa0a13ff spl set id: 96fe2cc7-e812-4d39-8f11-bd3cc7411a21

Reported adverse events (FAERS/openFDA)#

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