NDC Code(s) : 57243-370-16
Packager : Salado Sales Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Advanced Hand SanitizerAlcohol GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-370
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL(UNII: 3K9958V90M)
(ALCOHOL - UNII:3K9958V90M) 		ALCOHOL70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE/CAPRATE(UNII: G7515SW10N)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE(UNII: 0A5MM307FC)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 809Y72KV36)
SULISOBENZONE(UNII: 1W6L629B4K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57243-370-1659 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 11/12/2012

LABELER - Salado Sales Inc.(009830555)

REGISTRANT - Nice-Pak Products, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091514 manufacture(57243-370)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091520 manufacture(57243-370)

PRINCIPAL DISPLAY PANEL

CVP ®

HEALTH

ADVANCED

HAND SANITZIER

KILLS MORE THAN 99.99% OF GERMS*

2 FL OZ (59 mL)

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