Label: PIRANHA BRAND FOAMING ALCOHOL HAND SANITIZER- foaming hand sanitizer solution
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Contains inactivated NDC Code(s)
NDC Code(s): 61625-688-41 - Packager: Bio Shine, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 11, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PIRANHA BRAND FOAMING ALCOHOL HAND SANITIZER
foaming hand sanitizer solutionProduct 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)
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