BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN- benzalkonium chloride liquid

BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin by

Drug Labeling and Warnings

BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin 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, citric acid, caprylyl/capryl glucoside, citrus reticulata (mandarin orange) peel oil, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, glycine soja oil, triethyl citrate, tocopherol

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

babyganics™

alcohol-free
foaming hand sanitizer

mandarin

moisturizing formula non-allergenic
kills 99.9% of germs* dermatologist tested

formulated without: parabens sulfates
phthalates dyes synthetic fragrances

Discover which of our ingredients are
Certified Organic on back panel.

8.45 FL OZ (250 mL)

1110398

INGREDIENTS AND APPEARANCE

BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-4000
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: 59062-4000-2	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/15/2013
2	NDC: 59062-4000-5	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/15/2013
3	NDC: 59062-4000-1	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/15/2013
4	NDC: 59062-4000-3	2 in 1 CARTON	08/15/2013
4	NDC: 59062-4000-5	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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)