PIRANHA BRAND FOAMING ANTIBACTERIAL HAND- foaming antibacterial hand soap with aloe and vitamin e solution

Piranha Brand Foaming Antibacterial Hand by

Drug Labeling and Warnings

Piranha Brand Foaming Antibacterial Hand 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

Triclosan 0.5% w/w.......Antibacterial Agent

INACTIVE INGREDIENT

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Glycerin, Polyquaternium-7, Aloe Barbadensis Leaf, Tocopheryl Acetate, Disodium Cocamido MIPA-Sulfosuccinate, Tetrasodium EDTA, Fragance, Citric Acid, Polyquaternium-10, DMDM Hydantoin, Yellow 5, Red 33. 

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

For external use only.

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

Stop use and ask a doctor if, in rare instances, redness or irritation develop and persists for more than 72 hours.

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

PURPOSE

For handwashing to decrease bacteria on skin.

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

INDICATIONS & USAGE

For handwashing to decrease bacteria on skin.

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

Stop use and ask a doctor if, in rare instances, redness or irritation develop and persists for more than 72 hours.

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

PRINCIPAL DISPLAY PANEL

  61625-689-41.jpg

INGREDIENTS AND APPEARANCE

PIRANHA BRAND FOAMING ANTIBACTERIAL HAND 
foaming antibacterial hand soap with aloe and vitamin e solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61625-689
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	18.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
EDETATE SODIUM (UNII: MP1J8420LU)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61625-689-41	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	09/23/2013

Labeler - Bio Shine, Inc. (801231184)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(61625-689) , analysis(61625-689) , label(61625-689) , pack(61625-689)