AZER HAND SANITIZER- alcohol gel 
Azer Scientific, Inc.

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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Azer Hand Sanitizer

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin

CASE

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

Other information

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

BOTTLE LABELCASE LABELBOX16.9 fl. oz. (500 mL) NDC: 74086-650-02

AZER HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74086-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74086-650-02500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Azer Scientific, Inc. (137459512)
Registrant - Azer Scientific, Inc. (137459512)
Establishment
NameAddressID/FEIBusiness Operations
Azer Scientific, Inc.137459512repack(74086-650) , relabel(74086-650)
Establishment
NameAddressID/FEIBusiness Operations
Soleo Cosmetic Co., Ltd.557829412api manufacture(74086-650)

Revised: 4/2020
Document Id: a2a568de-7b76-09e5-e053-2995a90ac590
Set id: a2a55e3f-6e9c-3265-e053-2995a90af317
Version: 1
Effective Time: 20200406
 
Azer Scientific, Inc.