AZER HAND SANITIZER- alcohol gel

Azer Hand Sanitizer by

Drug Labeling and Warnings

Azer Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Azer Scientific, Inc., Soleo Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

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

When using this product Avoid contact with eyes, ears, mouth, entire body, or damaged skins.
Stop use and ask a doctor If redness or irritation develop and persist.
Keep out of reach of children If swallowed, get medical help or contact a Sanitizer Gel Poison Control center right away.

Directions

• Spread on both hands, rub in, let dry.

Other information

• Store at room temperature 34~86°F (1~30°C)
• 

Inactive ingredients

Water, Glycerin, Carbomer, Butylene Glycol, Phenoxyethanol, Arginine, Mugwort Extract, Yeast Extract, Luffa Extract, Fragrance

Keep out of reach of children

Keep out of reach of children

Purpose

Hand sanitizer to help reduce bacteria on the skin

Package Label - Principal Display Panel

16.9 fl. oz. (500 mL) NDC: 74086-650-02

INGREDIENTS AND APPEARANCE

AZER HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74086-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ARGININE (UNII: 94ZLA3W45F)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
WATER (UNII: 059QF0KO0R)
LUFFA (UNII: F0R3Y60C6V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74086-650-02	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Azer Scientific, Inc. (137459512)

Registrant - Azer Scientific, Inc. (137459512)

Establishment
Name	Address	ID/FEI	Business Operations
Azer Scientific, Inc.		137459512	repack(74086-650) , relabel(74086-650)

Establishment
Name	Address	ID/FEI	Business Operations
Soleo Cosmetic Co., Ltd.		557829412	api manufacture(74086-650)