国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
Midlab Incorporated
TOPICAL
OTC DRUG
OTC monograph not final
FIVESTAR- PCMX HAND SOAP SOAP MIDLAB INCORPORATED _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._ ---------- FIVESTAR pcmx hand soap soap PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:70 542-30 5 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CHLO RO XYLENO L (UNII: 0 F32U78 V2Q) (CHLOROXYLENOL - UNII:0 F32U78 V2Q) CHLOROXYLENOL 0 .1 g in 1 L Midlab Incorporated INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) METHYLCHLO RO ISO THIAZO LINO NE/METHYLISO THIAZO LINO NE MIXTURE (UNII: 15O9 QS218 W) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) SO DIUM SULFATE (UNII: 0 YPR6 5R21J) GLYCO L STEARATE (UNII: 0 324G6 6 D0 E) TRIMETHYLENEDIAMINETETRAACETIC ACID (UNII: 3F6 OA9 4EER) SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U) SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 ) PRODUCT CHARACTERISTICS COLOR white (Melo n o do r) S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70 542-30 5- 41 3.78 L in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n Pro duc t 0 2/0 1/20 17 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333A 0 2/0 1/20 17 LABELER - Midlab Incorporated (047371463) REGISTRANT - Midlab Incorporated (047371463) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Midlab Inco rpo rated 0 4737146 3 ma nufa c ture (70 542-30 5) Revised: 8/2018 阅读完整的文件