MIRACLE SPECIAL HAND SANITAIZER- 0.1% benzalkonium chloride instant hand sanitizer liquid 
Korea Miracle People Corporation 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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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) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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)

Benzalkonium chloride 0.1% 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

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

Other information

Inactive ingredients

glycerin, purified water

Package Label - Principal Display Panel

500ml NDC: 77524-0140-1500ml NDC: 77524-0140-1

MIRACLE SPECIAL HAND SANITAIZER 
0.1% benzalkonium chloride instant hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77524-0140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 2.5 mL  in 500 mL
WATER (UNII: 059QF0KO0R) 497 mL  in 500 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77524-0140-1500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Korea Miracle People Corporation Co.,Ltd (693710617)
Registrant - Korea Miracle People Corporation Co.,Ltd (693710617)
Establishment
NameAddressID/FEIBusiness Operations
Korea Miracle People Corporation Co.,Ltd693710617manufacture(77524-0140)

Revised: 6/2020
Document Id: a80a83be-c45c-5e56-e053-2995a90a2038
Set id: a80aab95-af7f-77e8-e053-2995a90a171a
Version: 1
Effective Time: 20200614
 
Korea Miracle People Corporation Co.,Ltd