HOLY CLEAN GUYS REALLY CLEAN HANDS ANTISEPTIC GEL

Manufacturer: Frozen Wheels, Llc | Neoingenium Labs, S.A. de C.V.
Effective date: 2020-05-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:14:24

Label at a glance#

ProductHOLY CLEAN GUYS ANTISEPTIC HAND SANITIZER

Active ingredientALCOHOL

Label structure9 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Contacts and useful links#

PhoneLabel contact786-265-1879

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

demineralized water, glycerin, carbomer, aloe vera extract, triethanolamine, disodium EDTA.

SPL UNCLASSIFIED SECTION

THE IMPECCABLE EXPERTS

TOPICAL FORMULA

NON-STERILE SOLUTION

parabens FREE

NO ANIMAL TESTING

QUESTIONS?

786-265-1879

Made in México.

Imported & distributed by:

Frozen Wheels, LLC

16565 NW 15th Ave.

Miami, FL 33169

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	3
581662	ethanol 0.7 ML/ML Topical Gel	SCD	3
581662	ethanol 70 % Topical Gel	SY	3
581662	ethyl alcohol 70 % Topical Gel	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77031-818-02	2021-07-23	C162847	48780-1	c7ccaba7-1080-fd44-e053-dadaa90aa01b	HOLY CLEAN GUYS REALLY CLEAN HANDS ANTISEPTIC GEL
77031-818-08	2021-07-23	C162847	48780-1	c7ccaba7-1080-fd44-e053-dadaa90aa01b	HOLY CLEAN GUYS REALLY CLEAN HANDS ANTISEPTIC GEL
77031-818-16	2021-07-23	C162847	48780-1	c7ccaba7-1080-fd44-e053-dadaa90aa01b	HOLY CLEAN GUYS REALLY CLEAN HANDS ANTISEPTIC GEL
77031-818-33	2021-07-23	C162847	48780-1	c7ccaba7-1080-fd44-e053-dadaa90aa01b	HOLY CLEAN GUYS REALLY CLEAN HANDS ANTISEPTIC GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77031-818-02	HOLY CLEAN GUYS ANTISEPTIC HAND SANITIZER	60 mL in 1 BOTTLE, PLASTIC	GEL	60	3
77031-818-08	HOLY CLEAN GUYS ANTISEPTIC HAND SANITIZER	237 mL in 1 BOTTLE, PLASTIC	GEL	237	3
77031-818-16	HOLY CLEAN GUYS ANTISEPTIC HAND SANITIZER	500 mL in 1 BOTTLE, PLASTIC	GEL	500	3
77031-818-33	HOLY CLEAN GUYS ANTISEPTIC HAND SANITIZER	1000 mL in 1 BOTTLE, PLASTIC	GEL	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77031-818	HOLY CLEAN GUYS ANTISEPTIC HAND SANITIZER (ALCOHOL) GEL [FROZEN WHEELS, LLC]	3	Legacy NDC, 4 package rows	20200523_dfe8ff03-739a-49e9-9233-ecf5aedee981.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

HOLY CLEAN GUYS ANTISEPTIC HAND SANITIZER
Alcohol
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ALOE VERA LEAF
TROLAMINE
EDETATE DISODIUM ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77031-818	77031-818-02, 77031-818-08, 77031-818-16, 77031-818-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
TROLAMINE	9O3K93S3TK	IACT
EDETATE DISODIUM ANHYDROUS	8NLQ36F6MM	IACT

Source Document#

Source XML · Source PDF

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
2d4a44d0-7c4d-44e5-9316-31d0e627ddd8			dfe8ff03-739a-49e9-9233-ecf5aedee981	2020-05-20	Warnings	Exact identifier spl id: 2d4a44d0-7c4d-44e5-9316-31d0e627ddd8 spl set id: dfe8ff03-739a-49e9-9233-ecf5aedee981

Reported adverse events (FAERS/openFDA)#

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