BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER BERRY BERRY- benzalkonium chloride liquid BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER CUPCAKE- benzalkonium chloride liquid

BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Cupcake by

Drug Labeling and Warnings

BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Cupcake by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics, Voyant Beauty, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

59062-4201

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	505G(a)(3)	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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	505G(a)(3)	06/06/2022

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Establishment
Name	Address	ID/FEI	Business Operations
Voyant Beauty, Inc.		253610042	MANUFACTURE(59062-4101, 59062-4201)