PIRANHA BRAND ALCOHOL FREE FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E- foaming instant hand sanitizer 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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Piranha Brand Alcohol Free Foaming Instant Hand Sanitizer with Aloe and Vitamin E

Benzethonium Chloride 0.2% w/w.....Antibacterial Agent

Water, Fragrance, Aloe Barbadensis Leaf, Tocopheryl Acetate, Cocamidopropyl Betaine, Propylene Glycol, Phenoxyethanol, PEG-7 Glyceryl Cocoate, Tetrasodium EDTA. 

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

For external use only.

Avoid contact with eyes. If 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.

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

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

Avoid contact with eyes. If 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. If swallowed, contact a physician or poison control center.

61625-682-41.jpg  61625-682-41.jpg 

PIRANHA BRAND ALCOHOL FREE FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E 
foaming instant hand sanitizer with aloe and vitamin e solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61625-682
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE7.56 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61625-682-411000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/17/2013
Labeler - Bio Shine, Inc. (801231184)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(61625-682) , analysis(61625-682) , label(61625-682) , pack(61625-682)

Revised: 3/2014
Document Id: d0ada552-23e6-40be-b70a-9732a5922103
Set id: d0fb71fe-518b-46c0-b01b-ea8a9c7bffc7
Version: 1
Effective Time: 20140311
 
Bio Shine, Inc.