NDC Code(s) : 75957-001-01, 75957-001-02, 75957-002-01
Packager : Nehemiah Manufacturing

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pampers KandooBenzalkonium Chloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75957-001
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride(UNII: F5UM2KM3W7)
(Benzalkonium - UNII:7N6JUD5X6Y) 		Benzalkonium Chloride1.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Lauramine Oxide(UNII: 4F6FC4MI8W)
Phenoxyethanol(UNII: HIE492ZZ3T)
Polysorbate 20(UNII: 7T1F30V5YH)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Panthenol(UNII: WV9CM0O67Z)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)(UNII: 0L414VCS5Y)
Edetate Sodium(UNII: MP1J8420LU)
Borago Officinalis Seed(UNII: 2GXJ790US0)
CITRUS AURANTIUM FRUIT OIL(UNII: 59JDQ5VT0T)
OENOTHERA BIENNIS(UNII: 76UI55V071)
Pentylene Glycol(UNII: 50C1307PZG)
TAMARINDUS INDICA SEED(UNII: 6AHP8A7OML)
OENOTHERA BIENNIS FLOWER(UNII: Y1YXJ1M6Z5)
Ascorbyl Palmitate(UNII: QN83US2B0N)
Alpha-Tocopherol(UNII: H4N855PNZ1)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75957-001-0150 mL in 1 BOTTLE, PUMP
2NDC:75957-001-02250 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 02/14/2011
Pampers KandooBenzalkonium Chloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75957-002
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride(UNII: F5UM2KM3W7)
(Benzalkonium - UNII:7N6JUD5X6Y) 		Benzalkonium Chloride2.6 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
Polysorbate 20(UNII: 7T1F30V5YH)
Phenoxyethanol(UNII: HIE492ZZ3T)
Lauramine Oxide(UNII: 4F6FC4MI8W)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)(UNII: 0L414VCS5Y)
Benzoic Acid(UNII: 8SKN0B0MIM)
Edetate Sodium(UNII: MP1J8420LU)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Dehydroacetic Acid(UNII: 2KAG279R6R)
CITRUS AURANTIUM FRUIT OIL(UNII: 59JDQ5VT0T)
OENOTHERA BIENNIS FLOWER(UNII: Y1YXJ1M6Z5)
Panthenol(UNII: WV9CM0O67Z)
Pentylene Glycol(UNII: 50C1307PZG)
TAMARINDUS INDICA SEED(UNII: 6AHP8A7OML)
Ascorbyl Palmitate(UNII: QN83US2B0N)
Alpha-Tocopherol(UNII: H4N855PNZ1)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C GREEN NO. 5(UNII: 8J6RDU8L9X)
Product Characteristics
Color GREEN Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75957-002-01250 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 02/14/2011

PRINCIPAL DISPLAY PANEL

FOAM for
better coverage

Pampers®
Kandoo ®

FOAMING

Hand Sanitizer
MOISTURIZING WITH
Vitamin E

ALCOHOL FREE
KILLS 99.9% OF GERMS*

8.4 FL OZ (250 mL)

Principal Display Panel - 250 mL Bottle Label

PRINCIPAL DISPLAY PANEL

Pampers®
Kandoo ®

Magic
Melon™

ANTIBACTERIAL

Hand Soap
MOISTURIZING WITH Vitamin E

8.4 FL OZ (250 mL)

Principal Display Panel - 250 mL Bottle Label