KTM power hand

Manufacturer: Regenera y Transforma, S.A. de C.V.
Effective date: 2020-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:19:10

Label at a glance#

ProductKTM power hand

Active ingredientALCOHOL

Label structure9 sections

Dosage and administration

Place enough product on hands to cover all surfaces thoroughly. 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)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl 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.

When using this product

Do not use on open skin wounds.

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use in children less than 2 months of age.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces thoroughly. 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

Water, Carbomer homopolymer Type C, Glycerin, Triethanolamine.

SPL UNCLASSIFIED SECTION

NO RINSING

70% ALCOHOL

"KILLS THE MOST GERMS"

Moisturizing

ANTISEPTIC

HAND RUB

ventas@kaizentm.com

Distributed by:

Kaizen Transfer of USA LLC.

611 Shiloh Dr, Ste. 5 Laredo, TX. 78045

Manufactured by:

Regenera y Transforma S.A.de C.V.

Made in México

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	2
581662	ethanol 70 % Topical Gel	SY	2
581662	ethyl alcohol 70 % Topical Gel	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78499-100-01	2022-01-28	C162847	48780-1	d6a99b39-5b56-a426-e053-dadaa90af4c2	KTM POWER HAND HAND SANITIZER
78499-100-04	2022-01-28	C162847	48780-1	d6a99b39-5b56-a426-e053-dadaa90af4c2	KTM POWER HAND HAND SANITIZER
78499-100-05	2022-01-28	C162847	48780-1	d6a99b39-5b56-a426-e053-dadaa90af4c2	KTM POWER HAND HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78499-100-01	KTM power hand	1000 mL in 1 BOTTLE	GEL	1000	2
78499-100-04	KTM power hand	4000 mL in 1 BOTTLE	GEL	4000	2
78499-100-05	KTM power hand	3780 mL in 1 BOTTLE	GEL	3780	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78499-100	KTM POWER HAND (ETHYL ALCOHOL) GEL [REGENERA Y TRANSFORMA, S.A. DE C.V.]	2	Legacy NDC, 3 package rows	20200627_5389810a-2887-4277-b863-7ef422e6070b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

KTM power hand
Ethyl alcohol
ALCOHOL
WATER
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCERIN
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78499-100	78499-100-01, 78499-100-04, 78499-100-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
WATER	059QF0KO0R	IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	IACT
GLYCERIN	PDC6A3C0OX	IACT
TROLAMINE	9O3K93S3TK	IACT

Source Document#

Source XML

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
1a3d92c1-5479-4034-bc1c-3a4d7fa5c21f			5389810a-2887-4277-b863-7ef422e6070b	2020-06-25	Warnings	Exact identifier spl id: 1a3d92c1-5479-4034-bc1c-3a4d7fa5c21f spl set id: 5389810a-2887-4277-b863-7ef422e6070b

Reported adverse events (FAERS/openFDA)#

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