PAUL MITCHELL HAND SANITIZER- alcohol liquid

Paul Mitchell Hand Sanitizer by

Drug Labeling and Warnings

Paul Mitchell Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Bocchi Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Alcohol 80% v/v

PURPOSE

Purpose

Antiseptic

WARNINGS

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

WHEN USING

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

INDICATIONS & USAGE

Use(s)

• Hand sanitizer to help reduce bacteria that potentially can cause disease.
• For use when soap and water are not available.

DOSAGE & ADMINISTRATION

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

Other information

• Store between 15°-30°C (59°-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive ingredients Glycerin, Hydrogen Peroxide, Purified Water USP

DO NOT USE

Do not use

• In children less than 2 months of age
• On open skin wounds

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:

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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAUL MITCHELL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57702-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57702-106-03	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2020	12/31/2021
2	NDC: 57702-106-34	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2020	12/31/2021
3	NDC: 57702-106-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/21/2020	12/31/2021

Labeler - Bocchi Laboratories (013579387)