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NDC 59062-4101-01 BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry Berry 0.12 mg/mL Details

BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry Berry 0.12 mg/mL

BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry Berry is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by KAS Direct LLC dba BabyGanics. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	59062-4101
Product ID	59062-4101_945a28ae-21a1-4ba2-8aed-8e907e449c19
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	BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry Berry
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.12
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	KAS Direct LLC dba BabyGanics
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59062-4101-01 (59062410101)

Pricing Information	N/A
NDC Package Code	59062-4101-1
Billing NDC	59062410101
Package	250 mL in 1 BOTTLE, PUMP (59062-4101-1)
Marketing Start Date	2022-06-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 75ae3b5e-b583-4b80-b4ab-5cc40978ca30 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium chloride 0.12%

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, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops, or if condition lasts 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, propanediol, cocamidopropylamine oxide, cetrimonium chloride, pyrus malus (apple) fruit extract, aloe barbadensis leaf juice1, calendula officinalis flower extract1, chamomilla recutita (matricaria) flower extract1, olea europaea (olive) leaf extract1, glycerin, citric acid, fragrance2

1: Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.

Learn more about these and all our ingredients and the choices we make at babyganics.com/products
2: Product formulated using ingredients chosen with kids in mind, including plant-derived fragrance.

PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - NDC 59062-4101

kids

by babyganics®

hand sanitizer

berry berry

kills 99.9% of bacteria*

alcohol-free, moisturizing

Discover which of our

ingredients are certified organic

on the back panel.

8.45 FL OZ (249 mL)

1137406

Principal Display Panel - 249 mL Bottle Label - NDC 59062-4101

PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - NDC 59062-4201

kids

by babyganics®

hand sanitizer

cupcake

kills 99.9% of bacteria*

alcohol-free, moisturizing

Discover which of our

ingredients are certified organic

on the back panel.

8.45 FL OZ (249 mL)

1137393

Principal Display Panel - 249 mL Bottle Label - NDC 59062-4201

INGREDIENTS AND APPEARANCE

BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER BERRY BERRY

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59062-4101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
APPLE (UNII: B423VGH5S9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59062-4101-1	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/06/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	06/06/2022

BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER CUPCAKE

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59062-4201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
APPLE (UNII: B423VGH5S9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59062-4201-1	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/06/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	06/06/2022

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 6/2022

Document Id: 945a28ae-21a1-4ba2-8aed-8e907e449c19

Set id: 75ae3b5e-b583-4b80-b4ab-5cc40978ca30

Version: 1

Effective Time: 20220609