HANDPOWER CLEANER (TM) HAND SANITIZER- benzalkonium chloride liquid

HANDPOWER CLEANER (TM) Hand Sanitizer by

Drug Labeling and Warnings

HANDPOWER CLEANER (TM) Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by handpower solutions inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient_____________________________________Purpose

Benzalkonium Chloride 0.1% ………………………………..……... Antiseptic

Purpose

Active Ingredient_____________________________________Purpose

Benzalkonium Chloride 0.1% ………………………………..……... Antiseptic

Uses.

Uses: Hand sanitizer to help reduce bacteria and other pathogens that potentially can cause disease. For use when soap and water are not available. Not for use on the face or other sensitive areas.

Warnings:

Warnings: FOR EXTERNAL USE ONLY. DO NOT DRINK. Do not use on food surfaces or pets. Do not combine with other chemicals.

DO NOT USE on children less than 6 months of age.

When using this product

When using this productkeep out of eyes, ears, mouth, and other body openings. In case of contact with eyes, rinse eyes thoroughly with water, remove contact lenses and continue rinsing eyes.

Stop use

Stop use and ask a doctor if irritation or rash occurs.

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. 1 (800) 222-1222

Directions:

Directions:Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 9 years of age when using this product to avoid swallowing.

Other information:

Other information: Store between 10-30C (50-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients:

Inactive ingredients: Glycerin USP, fragrance, deionized water

FDA REGISTERED NDC # 76915-1001-1

N/A

Lot # ####-##-## Recommended use-by date: MM/DD/YYYY

Photo of front of product with front label

Photo of rear of bottle with rear label

INGREDIENTS AND APPEARANCE

HANDPOWER CLEANER (TM) HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76915-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.0025 mL  in 1 mL
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)	0.004 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76915-1001-1	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/09/2020

Labeler - handpower solutions inc (130855904)

Registrant - handpower solutions inc (130855904)

Establishment
Name	Address	ID/FEI	Business Operations
handpower solutions inc		130855904	manufacture(76915-1001)