KTM POWER HAND- ethyl alcohol gel

KTM power hand by

Drug Labeling and Warnings

KTM power hand by is a Otc medication manufactured, distributed, or labeled by Regenera y Transforma, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active ingredients

Ethyl alcohol 70% v/v

purpose

antiseptic

Use[s]

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

Warnings

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

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

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

Directions

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

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

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

INGREDIENTS AND APPEARANCE

KTM POWER HAND 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78499-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78499-100-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
2	NDC: 78499-100-04	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
3	NDC: 78499-100-05	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020

Labeler - Regenera y Transforma, S.A. de C.V. (951577608)

Establishment
Name	Address	ID/FEI	Business Operations
Regenera y Transforma, S.A. de C.V.		951577608	manufacture(78499-100)