HUMETEC Hand Sanitizer Gel

HUMETEC Hand Sanitizer Gel by

Drug Labeling and Warnings

HUMETEC Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Houston Medical Technologies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HUMETEC HAND SANITIZER GEL- alcohol gel 
Houston Medical Technologies 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.

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HUMETEC Hand Sanitizer Gel

Drug facts

Active ingredient

Ethyl Alcohol 75 % (v/v)

Purpose

Antimicrobial

Uses:

Hand Sanitizer to help reduce bacteria that could potentially cause disease.

Warnings:

For external use only. Flammable. Keep away from heat or flame.

Do not use:

on children under 2 months of age or 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 consult 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

Apply entire contents of packet onto hands and rub until dry.
Supervise children under 6 years of age when using this product to prevent swallowing.

Other information

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

Inactive ingredients

Aqua (water), Glycerin, Carbomer, Aminomethyl propanol. Fragrance

Package Labeling:60ml

Package Labeling:250ml

Package Labeling:500ml

Package Labeling:1000ml

Package Labeling: 50ct of 2mL

HUMETEC HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80178-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80178-009-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020	10/31/2023
2	NDC: 80178-009-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020	10/31/2023
3	NDC: 80178-009-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020	10/31/2023
4	NDC: 80178-009-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020	10/31/2023
5	NDC: 80178-009-05	50 in 1 PACKAGE	04/01/2020	10/31/2023
5		2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020	10/31/2023

Labeler - Houston Medical Technologies LLC (117519098)

Revised: 10/2022

Document Id: eb98ce2f-320e-2098-e053-2995a90a9426

34390-5

Set id: ada333bc-2f64-0241-e053-2995a90a800f

Version: 6

Effective Time: 20221022