AKTIVE SANITIZING WIPES- alcohol cloth 
Hall Global LLC

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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Wipe

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. Ethyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerin (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water\
  5. Fragrance

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)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Use wipes on hands, skin, or surfaces to decrease bacteria, recomended for repeated use.

Warnings

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

Do not use

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 immediately

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

Wet hands thoroughtly with product, and allow to dry. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age should be supervised when using this product.

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water, fragrance

Package Label - Principal Display Panel

Package Label Principal Display PanelPackage Label Principal Display Panel

AKTIVE SANITIZING WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81156-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81156-001-75375 mL in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
2NDC:81156-001-16800 mL in 1 CANISTER; 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 - Hall Global LLC (117729725)
Registrant - Hall Global LLC (117729725)
Establishment
NameAddressID/FEIBusiness Operations
Hall Global LLC117729725manufacture(81156-001)

Revised: 11/2020
Document Id: b4cd4b64-7da4-da44-e053-2995a90a8953
Set id: b4cd8c76-83c7-551d-e053-2995a90aaedb
Version: 1
Effective Time: 20201123
 
Hall Global LLC