Piranha Brand Foaming Antibacterial Hand

PIRANHA BRAND FOAMING ANTIBACTERIAL HAND- foaming antibacterial hand soap with aloe and vitamin e solution
Bio Shine, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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. If swallowed, contact a physician or poison control center.

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.

For handwashing to decrease bacteria on skin.

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

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.

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61625-689-41	1000 mL in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/23/2013

Labeler - Bio Shine, Inc. (801231184)

Registrant - Kutol Products Company, Inc. (004236139)

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