OTC Medication Information: KTM Power Hand

KTM POWER HAND- alcohol gel
Regenera y Transforma, S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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

IMAGE
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IMAGE
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KTM POWER HAND
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78499-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCERIN
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78499-100-01 1000 mL in 1 BOTTLE None
2 NDC:78499-100-04 4000 mL in 1 BOTTLE None
3 NDC:78499-100-05 3780 mL in 1 BOTTLE None
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 Operations
Regenera y Transforma, S.A. de C.V. 951577608 manufacture (78499-100)

Revised: 06/2020 Regenera y Transforma, S.A. de C.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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