BABYGANICS ALCOHOL FREE FOAMING HAND SANITIZER- benzalkonium chloride liquid

BabyGanics Alcohol Free Foaming Hand Sanitizer by

Drug Labeling and Warnings

BabyGanics Alcohol Free Foaming Hand Sanitizer 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.

Questions or comments?

Contact us! 1-800-378-7803
www.babyganics.com

SPL UNCLASSIFIED SECTION

Dist. by:
KAS Direct, LLC
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

babyganics®

alcohol-free
foaming hand sanitizer

fragrance free ∙ moisturizing formula
non-allergenic ∙ kills 99.9% of germs*

no: triclosan, parabens, sulfates,
phthalates, artificial fragrances or dyes

1.69 FL OZ (50mL)

043-10036-01

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

babyganics®

alcohol-free
foaming hand sanitizer

fragrance free ∙ moisturizing formula
non-allergenic ∙ kills 99.9% of germs*
pediatrician & dermatologist tested

no: triclosan, parabens, sulftates, phthalates,
artificial fragrances or dyes

8.45 FL OZ (250mL)

040-10050-01

INGREDIENTS AND APPEARANCE

BABYGANICS ALCOHOL FREE FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1003
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1003-1	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	08/15/2013

BABYGANICS ALCOHOL FREE FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1005
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1005-1	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	08/15/2013

Labeler - KAS Direct LLC dba BabyGanics (002764605)