TRADEMARK HAND SANITIZER- alcohol gel

Trademark Hand Sanitizer by

Drug Labeling and Warnings

Trademark Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Organikisimo, S.A. de C:V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

For sanitizing to help reduce bacteria on the skin that potentially can cause disease.

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.


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

KEEP OUT OF REACH OF CHILDREN

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

Inactive ingredients

Water, Carbomer, Glycerin,Triethanolamine, Tocopheryl Acetate (Vitamin E).

Package Label - TRADEMARK 59 ml NDC:

79337-172-01

59 ml NDC: 79337-172-01

Package Label - TRADEMARK 250 ml NDC:

79337-172-02

250 ml NDC: 79337-172-02

Package Label - TRADEMARK 1000 ml NDC:

79337-172-03

1000 ml NDC: 79337-172-03

Package Label - TRADEMARK 3785 ml NDC:

79337-172-04

3785 ml NDC: 79337-172-04

INGREDIENTS AND APPEARANCE

TRADEMARK HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79337-172
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
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.8 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.3 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.6 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.15 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79337-172-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020
2	NDC: 79337-172-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020
3	NDC: 79337-172-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020
4	NDC: 79337-172-04	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	11/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/19/2020

Labeler - Organikisimo, S.A. de C:V. (951579669)

Registrant - Organikisimo, S.A. de C:V. (951579669)

Establishment
Name	Address	ID/FEI	Business Operations
Organikisimo, S.A. de C:V.		951579669	manufacture(79337-172)