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. 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, 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, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance1

1 Learn about these and all our ingredients and the choices we make at babyganics.com/products

SPL UNCLASSIFIED SECTION

dist. by KAS Direct, LLC
San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - Berry Berry

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)

1123758

PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - Cupcake

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)

1123771

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: 59062-4100
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-4100-1	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	505G(a)(3)	02/15/2021

BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER CUPCAKE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-4200
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-4200-1	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	505G(a)(3)	02/15/2021

Labeler - KAS Direct LLC dba BabyGanics (002764605)