ANTISEPTIC HAND SANITIZER- alcohol gel

Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only
Flammable, keep away from fire or flame.

Do not use 

in the eyes

Stop use and ask a doctor if

• irritation and redness develop 
• condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

wet hands thoroughly with product and allow to dry without wiping

Other information

• do not store above 110°F (43°C)
• may discolor certain fabrics, or may harm some wood finishes and plastics

Inactive ingredients

Water, glycerin, fragrance, tocopherol acetate, carbomer and triethanolamine.

Questions or comments?

+1 818 763 8698

Package Labeling: (

65055-600-00)

Package Labeling: (

65055-600-01)

Package Labeling: (

65055-600-02)

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65055-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65055-600-00	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
2	NDC: 65055-600-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
3	NDC: 65055-600-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/24/2020

Labeler - Laboratorios Jaloma S.A. de C.V. (811122357)