Sensimedical® Hand Sanitizer Gel 70% Alcohol

Hand Sanitizer Gel 70% Alcohol by

Drug Labeling and Warnings

Hand Sanitizer Gel 70% Alcohol by is a Otc medication manufactured, distributed, or labeled by SENSIMEDICAL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL 70% ALCOHOL- hand sanitizer gel 70% alcohol gel 
SENSIMEDICAL LLC

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.

----------

Sensimedical® Hand Sanitizer Gel 70% Alcohol

Drug Facts

Active Ingredient(s)

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.

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.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

• Store between 15 - 30°C (59 - 86°F)
• Avoid freezing and excessive heatabove 40°C (104°F)

Inactive Ingredients

Glycerin, Polyacrylic Acid (Carbomer), Hydrogen Peroxide, Water

SensiMedical®Hand Sanitizer Gel 70% Alcohol

kills 99% of bacteria and germs

Manufactured for:

Sensimedical LLC 19495 Biscayne Blvd.  Suite 609.  Aventura FL 33180

Tel.: (305) 692-7641

www.sensimedical.com

Made in Guatemala

NDC: 78718-763

HAND SANITIZER GEL 70% ALCOHOL 
hand sanitizer gel 70% alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78718-763
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
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)	1.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78718-763-01	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/08/2020	06/28/2021
2	NDC: 78718-763-02	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/08/2020	06/28/2021
3	NDC: 78718-763-03	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/08/2020	06/28/2021
4	NDC: 78718-763-04	532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/08/2020	06/28/2021
5	NDC: 78718-763-05	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/08/2020	06/28/2021
6	NDC: 78718-763-06	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/08/2020	06/28/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/08/2020	06/28/2021

Labeler - SENSIMEDICAL LLC (117526048)

Revised: 6/2021

Document Id: b5344d85-8da2-492a-ad30-b1b8713dc1a8

34390-5

Set id: b7d1a319-9186-45c4-a7bc-6fd99339247c

Version: 4

Effective Time: 20210628