ALCOHOL DISINFECTANT- alcohol liquid 
Qingdao Maixing Biotechnology Co.,Ltd

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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Hand Sanitizer

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: disinfection and antiseptic

Purpose

Antiseptic, Hand Sanitizer

purpose:disinfection and antiseptic

Use

Suitable for sterilization and disinfection of the surface of the object and the complete skin of the human body.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

Keep out of eyes.in case of contact with eyes,flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

stop use and ask a doctor if irritation and redness develop,condition persists for more tahn 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

this product is for extermal use.apply this product to skin,hands and general objects
this product is not a substitute for drugs or medical devices
use with caution;infants, pregnant women and breastfeeding women
keep out of reach of children,
do not use on children 6 years old.do not use on open skin wounds

Other information

Inactive ingredients

water

Package Label - Principal Display Panel

50 mL NDC: 75711-003-01

ALCOHOL DISINFECTANT 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75711-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75711-003-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/22/2020
Labeler - Qingdao Maixing Biotechnology Co.,Ltd (417832907)

Revised: 4/2020
Document Id: a4414e2a-4aa9-718c-e053-2995a90a7217
Set id: a3c7969b-0f64-6aea-e053-2995a90a7679
Version: 3
Effective Time: 20200422
 
Qingdao Maixing Biotechnology Co.,Ltd