ASSASSIN HAND SANITIZER- alcohol gel 
E.R.E.

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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Assassin Hand Sanitizer 70% 500 ml

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)

Alcohol 70% 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 USP, Triethanolamine, Alkyl Acrylate Crosspolymer, Fragrance, Aloe vera

Package Label - Principal Display Panel

Label 500

500 mL NDC: 80530-000-01

ASSASSIN HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80530-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 1 mL  in 500 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 500 mL
GLYCERIN (UNII: PDC6A3C0OX) 6 mL  in 500 mL
TROLAMINE (UNII: 9O3K93S3TK) 4.15 mL  in 500 mL
WATER (UNII: 059QF0KO0R) 136.55 mL  in 500 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 1.8 mL  in 500 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80530-000-01500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - E.R.E. (249883273)
Registrant - E.R.R (249883273)
Establishment
NameAddressID/FEIBusiness Operations
E.R.E249883273manufacture(80530-000)

Revised: 12/2022
Document Id: eff52842-7645-c4ec-e053-2995a90a6dc3
Set id: b12d47ef-5781-93b2-e053-2a95a90a8391
Version: 5
Effective Time: 20221216
 
E.R.E.