BABY ESSENTIALS GIFT SET- benzalkonium chloride kit

baby essentials gift set by

Drug Labeling and Warnings

baby essentials gift set by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

• for hand sanitizing to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• pump a small amount of foam into palm of hand
• rub thoroughly over all surfaces of both hands
• rub hands together briskly until dry

Inactive ingredients

water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, medium chain triglycerides, triethyl citrate, citrus reticulata (mandarin orange) peel oil, tocopherol, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - Kit Package

babyganics

baby
essentials
gift set

1- daily lotion chamomile verbena (9 FL OZ)
1- bubble bath chamomile verbena (9 FL OZ)
1- foaming shampoo+body wash chamomile verbena (7 FL OZ)
1- foaming dish & bottle soap fragrance free (3 FL OZ)
1- toy, table & highchair wipes fragrance free (25 wipes)
2- alcohol-free foaming hand sanitizer mandarin (50 ML)

Discover which ingredients are Certified Organic on bottom panel.

INGREDIENTS AND APPEARANCE

BABY ESSENTIALS GIFT SET 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-5000

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-5000-1	1 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	266 mL
Part 2	1 BOTTLE	266 mL
Part 3	1 BOTTLE	207 mL
Part 4	2 BOTTLE, PUMP	100 mL
Part 5	1 PACKAGE	25
Part 6	1 BOTTLE, DISPENSING	89 mL

Part 1 of 6

MOISTURIZING DAILY 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	water (UNII: 059QF0KO0R)
INGR	COCOA BUTTER (UNII: 512OYT1CRR)
INGR	cetyl alcohol (UNII: 936JST6JCN)
INGR	squalene (UNII: 7QWM220FJH)
INGR	decyl oleate (UNII: ZGR06DO97T)
INGR	shea butter (UNII: K49155WL9Y)
INGR	propanediol (UNII: 5965N8W85T)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	canola oil (UNII: 331KBJ17RK)
INGR	tocopherol (UNII: R0ZB2556P8)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	TOMATO SEED OIL (UNII: 7N87T9C06T)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
INGR	NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT)
INGR	RASPBERRY SEED OIL (UNII: 9S8867952A)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	stearic acid (UNII: 4ELV7Z65AP)
INGR	YELLOW WAX (UNII: 2ZA36H0S2V)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	sodium hydroxide (UNII: 55X04QC32I)
INGR	caprylyl glycol (UNII: 00YIU5438U)
INGR	TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
INGR	sorbic acid (UNII: X045WJ989B)
INGR	phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		266 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2015

Part 2 of 6

BUBBLE BATH 
bubble bath liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	water (UNII: 059QF0KO0R)
INGR	sodium lauroyl methyl isethionate (UNII: II6VCD3S6R)
INGR	disodium cocoamphodiacetate (UNII: 18L9G3U51M)
INGR	coco glucoside (UNII: ICS790225B)
INGR	lauryl glucoside (UNII: 76LN7P7UCU)
INGR	capryl/capramidopropyl betaine (UNII: 231H3ZT9NE)
INGR	TOMATO SEED OIL (UNII: 7N87T9C06T)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
INGR	NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT)
INGR	RASPBERRY SEED OIL (UNII: 9S8867952A)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ethylhexylglycerin (UNII: 147D247K3P)
INGR	sodium benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		266 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2015

Part 3 of 6

SQUEEZE AND FOAM SHAMPOO PLUS BODY WASH 
baby shampoos shampoo

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	water (UNII: 059QF0KO0R)
INGR	sodium lauroyl methyl isethionate (UNII: II6VCD3S6R)
INGR	CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
INGR	propanediol (UNII: 5965N8W85T)
INGR	BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
INGR	sodium lauroyl oat amino acids (UNII: FSW2K9B9N5)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	ethylhexylglycerin (UNII: 147D247K3P)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	trisodium ethylenediamine disuccinate (UNII: YA22H34H9Q)
INGR	dehydroacetic acid (UNII: 2KAG279R6R)
INGR	TOMATO SEED OIL (UNII: 7N87T9C06T)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
INGR	NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT)
INGR	RASPBERRY SEED OIL (UNII: 9S8867952A)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	sodium hydroxide (UNII: 55X04QC32I)
INGR	PHYTATE SODIUM (UNII: 88496G1ERL)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	AVOCADO (UNII: SDS87L369F)
INGR	tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		207 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2015

Part 4 of 6

BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN 
benzalkonium chloride liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cetrimonium chloride (UNII: UC9PE95IBP)
laurtrimonium chloride (UNII: A81MSI0FIC)
dihydroxyethyl cocamine oxide (UNII: 8AR51R3BL5)
glycereth-17 cocoate (UNII: 3057VPT0KC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
triethyl citrate (UNII: 8Z96QXD6UM)
TANGERINE (UNII: KH3E3096OO)
tocopherol (UNII: R0ZB2556P8)
ORANGE OIL (UNII: AKN3KSD11B)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-4000-5	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/15/2013

Part 5 of 6

TOY, TABLE AND HIGHCHAIR WIPES 
cleansing (cold creams, cleansing lotions, liquids, and pads) cloth

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	water (UNII: 059QF0KO0R)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	decyl glucoside (UNII: Z17H97EA6Y)
INGR	malic acid (UNII: 817L1N4CKP)
INGR	potassium sorbate (UNII: 1VPU26JZZ4)
INGR	gluconolactone (UNII: WQ29KQ9POT)
INGR	sodium benzoate (UNII: OJ245FE5EU)
INGR	DIRECT BLACK 19 (UNII: B91N7SNH1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		25 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2015

Part 6 of 6

FOAMING DISH AND BOTTLE SOAP 
bath soaps and detergents liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	water (UNII: 059QF0KO0R)
INGR	cocamidopropyl hydroxysultaine (UNII: 62V75NI93W)
INGR	lauramine oxide (UNII: 4F6FC4MI8W)
INGR	decyl glucoside (UNII: Z17H97EA6Y)
INGR	sodium lauroyl sarcosinate (UNII: 632GS99618)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		89 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	01/01/2015

Labeler - KAS Direct LLC dba BabyGanics (002764605)