PIPERWAIHANDSANITIZERMINTY- alcohol solution

piperwaiHandSanitizerminty by

Drug Labeling and Warnings

piperwaiHandSanitizerminty by is a Otc medication manufactured, distributed, or labeled by Piperwai, LLC, Cospro Development Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand rub 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) (62%, in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol.
3. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 62%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Rub

Use

Reduces the amount of bacteria on hands. Recommended for repeated use.

Warnings

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

Do not use

aviod contact with eyes.
In case of contact, flush thoroughly with water.

WHEN USING

When using this product aviod contact with eyes. In case of contact, flush thoroughly with water.
Stop use and ask a doctor if irritation occurs.

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.

Directions

Pump onto dry hands as needed coating evenly.
Allow to dry without wiping
Supervise children under 6 years old
Not recommended for infants.

Other information

Do not store above 105F

Inactive ingredients

Water, Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Piperita (Peppermint) Oil, Aminomethyl Propanol

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PIPERWAIHANDSANITIZERMINTY 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81741-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ROSEMARY (UNII: IJ67X351P9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81741-111-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2021

Labeler - Piperwai, LLC (047558690)

Registrant - Cospro Development Corp (785638821)

Establishment
Name	Address	ID/FEI	Business Operations
Cospro Development Corp		785638821	manufacture(81741-111) , pack(81741-111) , label(81741-111)