NDC Code(s) : 70542-303-41
Packager : Midlab Incorporated

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bright Solutions antisepticPCMX, Hand Soap SOAP
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70542-303
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL(UNII: 0F32U78V2Q)
(CHLOROXYLENOL - UNII:0F32U78V2Q) 		CHLOROXYLENOL1 g in 1 L
Inactive Ingredients
Ingredient Name Strength
BRONOPOL(UNII: 6PU1E16C9W)
COCAMIDOPROPYL HYDROXYSULTAINE(UNII: 62V75NI93W)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HEXAMETHYLINDANOPYRAN(UNII: 14170060AT)
PROPANEDIOL(UNII: 5965N8W85T)
VANILLIN(UNII: CHI530446X)
ALLYL HEXANOATE(UNII: 3VH84A363D)
SODIUM C14-16 OLEFIN SULFONATE(UNII: O9W3D3YF5U)
ETHYL CAPROATE(UNII: FLO6YR1SHT)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
.GAMMA.-NONALACTONE(UNII: I1XGH66S8P)
ALLYL AMYL GLYCOLATE(UNII: EMX89K493E)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
WATER(UNII: 059QF0KO0R)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)(UNII: 3A1I7376TC)
DIBROMOCYANOACETAMIDE(UNII: 7N51QGL6MJ)
Product Characteristics
Color white (Melon odor) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70542-303-413.78 L in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 02/01/2017

LABELER - Midlab Incorporated(047371463)

PRINCIPAL DISPLAY PANEL

Principal Display Panel