AKTIVE SANITIZING WIPES- alcohol cloth

Aktive Sanitizing Wipes by

Drug Labeling and Warnings

Aktive Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Hall Global LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

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

• Store between 60-90 F (15-30C)
• Avoid freezing and excessive heat above 104 F(40C). May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive ingredients

glycerin, hydrogen peroxide, purified water, fragrance

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

AKTIVE SANITIZING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81156-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81156-001-75	375 mL in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
2	NDC: 81156-001-16	800 mL in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Hall Global LLC (117729725)

Registrant - Hall Global LLC (117729725)

Establishment
Name	Address	ID/FEI	Business Operations
Hall Global LLC		117729725	manufacture(81156-001)