Label: PACIFIC ANTI-BACTERIAL HAND CLEANSE KIWI ESSENCE- triclosan gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50438-101-01 - Packager: Filo America
- 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 August 8, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PACIFIC ANTI-BACTERIAL HAND CLEANSE KIWI ESSENCE
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-101-01 500 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/08/2013 Labeler - Filo America (943873703) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(50438-101)