MONARCH HAND SANITIZER- alcohol gel

Monarch Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

for handwashing to decrease bacteria on skin. Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire and flame.

Do not use

in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop and 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. Rub into skin until dry. Do not wipe off. No rinsing required.

Other information

Store at no more than 86°F (30°C)

Inactive ingredients

Aminomethyl propanol, carbomer, glycerin, water.

Package Labeling:500ml

Package Labeling:3.7L

Package Labeling: 1L

Package Labeling: 60ml

INGREDIENTS AND APPEARANCE

MONARCH HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63710-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L  in 1 L

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63710-005-01	0.5 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/24/2020
2	NDC: 63710-005-02	3.7 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/24/2020
3	NDC: 63710-005-03	1 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/24/2020
4	NDC: 63710-005-04	0.06 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/24/2020

Labeler - Laboratorios Zeyco, S.A. de C.V. (812517605)