NDC Code(s) : 53942-439-16, 53942-439-34, 53942-439-45
Packager : Demoulas Super Markets, Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Advanced Hand SanitizerEthyl Alcohol GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-439
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)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GLYCERYL CAPRYLATE/CAPRATE(UNII: G7515SW10N)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
SULISOBENZONE(UNII: 1W6L629B4K)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53942-439-1659 mL in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product24/06/2015
2NDC:53942-439-34236 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product24/06/2015
3NDC:53942-439-45946 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 06/24/2015

LABELER - Demoulas Super Markets, Inc(007869647)

REGISTRANT - Nice-Pak Products, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091514 manufacture(53942-439)

Establishment
Name Address ID/FEI Business Operations
Nice-Pak Products, LLC 119091520 manufacture(53942-439)

PRINCIPAL DISPLAY PANEL

"More for your Dollar"

Market Basket ®

Advanced Hand Sanitizer with Aloe

Kills more than 99.99 % of germs*

**Compare to Purell ®Advanced Hand Sanitizer Soothing Gel

2 FL OZ (59 mL)

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