Label: PIRANHA BRAND FOAMING ANTIBACTERIAL HAND- foaming antibacterial hand soap with aloe and vitamin e solution
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Contains inactivated NDC Code(s)
NDC Code(s): 61625-689-41 - Packager: Bio Shine, Inc.
- Category: HUMAN OTC DRUG LABEL
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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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- PURPOSE
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
PIRANHA BRAND FOAMING ANTIBACTERIAL HAND
foaming antibacterial hand soap with aloe and vitamin e solutionProduct 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)