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NDC 59062-5000-01 baby essentials gift set Details

baby essentials gift set

baby essentials gift set is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by KAS Direct LLC dba BabyGanics. The primary component is .

Product Information

NDC	59062-5000
Product ID	59062-5000_32fd48bc-22cc-4ff8-b92e-af946e9cc1f7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	baby essentials gift set
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	KAS Direct LLC dba BabyGanics
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59062-5000-01 (59062500001)

Pricing Information	N/A
NDC Package Code	59062-5000-1
Billing NDC	59062500001
Package	1 KIT in 1 PACKAGE (59062-5000-1) * 207 mL in 1 BOTTLE * 25 CLOTH in 1 PACKAGE * 50 mL in 1 BOTTLE, PUMP (59062-4000-5) * 89 mL in 1 BOTTLE, DISPENSING * 266 mL in 1 BOTTLE * 266 mL in 1 BOTTLE
Marketing Start Date	2015-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7cd6121d-0c62-4429-8946-0fb1aa0eb0c2 Details

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

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

Part 2 of 6
BUBBLE BATH bubble bath liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

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

Part 3 of 6
SQUEEZE AND FOAM SHAMPOO PLUS BODY WASH baby shampoos shampoo

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

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

Part 4 of 6
BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN benzalkonium chloride liquid

Product Information
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

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

Part 6 of 6
FOAMING DISH AND BOTTLE SOAP bath soaps and detergents liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

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

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

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 11/2020

Document Id: 32fd48bc-22cc-4ff8-b92e-af946e9cc1f7

Set id: 7cd6121d-0c62-4429-8946-0fb1aa0eb0c2

Version: 1

Effective Time: 20201104

Search by Drug Name or NDC

NDC 59062-5000-01 baby essentials gift set Details

baby essentials gift set

Product Information

Package

Package Images

NDC 59062-5000-01 (59062500001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7cd6121d-0c62-4429-8946-0fb1aa0eb0c2 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - Kit Package

INGREDIENTS AND APPEARANCE

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