PIRANHA BRAND FOAMING ALCOHOL HAND SANITIZER- foaming hand sanitizer 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.

----------

Piranha Brand Foaming Alcohol Hand Sanitizer

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

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

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

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.

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

62625-688-41.jpg  61625-688-41.jpg

PIRANHA BRAND FOAMING ALCOHOL HAND SANITIZER 
foaming hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61625-688
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61625-688-411000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/27/2013
Labeler - Bio Shine, Inc. (801231184)
Registrant - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(61625-688) , analysis(61625-688) , label(61625-688) , pack(61625-688)

Revised: 3/2014
Document Id: bb8f9d5a-e53f-40f4-baa3-d854bf6d0477
Set id: faa91753-49c3-4496-a73f-66ca5f1fa2d6
Version: 1
Effective Time: 20140311
 
Bio Shine, Inc.