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Medical alcohol disinfectant

Medically reviewed by Drugs.com. Last updated on Apr 16, 2020.

Dosage form: liquid
Ingredients: ALCOHOL 0.75mL in 1mL
Labeler: Jiangxi Langhong Industry Co., Ltd.
NDC Code: 74463-201

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical alcohol disinfectant

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: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use
  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP

Package Label - Principal Display Panel

MEDICAL ALCOHOL DISINFECTANT 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74463-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:74463-201-0150 mL in 1 BOTTLE
2NDC:74463-201-0260 mL in 1 BOTTLE
3NDC:74463-201-03100 mL in 1 BOTTLE
4NDC:74463-201-04200 mL in 1 BOTTLE
5NDC:74463-201-05300 mL in 1 BOTTLE
6NDC:74463-201-06500 mL in 1 BOTTLE
7NDC:74463-201-072000 mL in 1 BOTTLE
8NDC:74463-201-085000 mL in 1 BOTTLE
9NDC:74463-201-0910000 mL in 1 BOTTLE
10NDC:74463-201-1020000 mL in 1 BOTTLE
11NDC:74463-201-11380 mL in 1 BOTTLE
12NDC:74463-201-121000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Jiangxi Langhong Industry Co., Ltd. (411429784)
Establishment
NameAddressID/FEIOperations
Jiangxi Langhong Industry Co., Ltd.411429784manufacture(74463-201)

 
Jiangxi Langhong Industry Co., Ltd.