PIRANHA BRAND FOAMING ALCOHOL HAND SANITIZER- foaming hand sanitizer solution

Piranha Brand Foaming Alcohol Hand Sanitizer by

Drug Labeling and Warnings

Piranha Brand Foaming Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Bio Shine, Inc., Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 62% v/v.......Antibacterial Agent

INACTIVE INGREDIENT

Water, AMP-C8-18 Perfluoroalkylethyl Phosphate, Glycerin.

PURPOSE

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

WARNINGS

For external use only.

FLAMMABLE. Keep away from heat or flames.

Avoid contact with eyes. If eye contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

INDICATIONS & USAGE

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Avoid contact with eyes. If eye contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, contact a physician or poison control center.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PIRANHA BRAND FOAMING ALCOHOL HAND SANITIZER 
foaming hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61625-688
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61625-688-41	1000 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/27/2013

Labeler - Bio Shine, Inc. (801231184)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(61625-688) , analysis(61625-688) , label(61625-688) , pack(61625-688)