BABYGANICS ALCOHOL-FREE HAND SANITIZER WIPES MANDARIN- benzalkonium chloride cloth

BabyGanics Alcohol-Free Hand Sanitizer Wipes by

Drug Labeling and Warnings

BabyGanics Alcohol-Free Hand Sanitizer Wipes 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 0.13%

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

• take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe.
• rub hands together briskly to dry without wiping
• dispose of wipe
• do not flush

Other information

• store in a cool dry place

Inactive ingredients

water, glycerin1, aloe barbadensis leaf extract1, tocopheryl acetate, polysorbate 20, decyl glucoside, gluconolactone, potassium sorbate, sodium benzoate, 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

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 20 Wipe Bag

20
wipes

babyganics

alcohol-free
hand sanitizing wipes

mandarin

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

formulated without: parabens sulfates
phthalates dyes synthetic fragrances

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

20 wipes ∙ 8 in x 6 in (20.3 cm x 15.2 cm)

INGREDIENTS AND APPEARANCE

BABYGANICS ALCOHOL-FREE HAND SANITIZER WIPES   MANDARIN
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1094
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)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1094-2	20 in 1 BAG	11/01/2016
1		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 59062-1094-3	100 in 1 CANISTER	11/01/2016
2		1 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 59062-1094-1	1 in 1 PACKET	11/01/2016
3		1 mL in 1 APPLICATOR; 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	11/01/2016

Labeler - KAS Direct LLC dba BabyGanics (002764605)