ANTIBACTERIAL FOAMING HAND WASH SPOOKY SUGAR COOKIE- benzalkonium chloride liquid

Antibacterial Foaming Hand Wash Spooky Sugar Cookie by

Drug Labeling and Warnings

Antibacterial Foaming Hand Wash Spooky Sugar Cookie by is a Otc medication manufactured, distributed, or labeled by Tonic Bath and Body Products Shenzhen Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

Avoid contact with eyes. If contact occurs flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of the reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Wet hands. Apply palmful to hands and forearms. Scrub thoroughly. Rinse and repeat. Dry thoroughly.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Benzophenone-3, Citric Acid, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, , Water, Disodium EDTA, FD&C Blue No. 1 (FD&C Red. No. 40 (CI42090), (CI16035), FD&C Yellow No. 5 (CI19140), Fragrance (Parfum), Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, Olea Europaea (Olive) Leaf Extract, Panthanol, Polysorbate 20, Propylene Glycol, Sodium Lauroamphoacetate.

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAMING HAND WASH SPOOKY SUGAR COOKIE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43333-453
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 13 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OXYBENZONE (UNII: 95OOS7VE0Y)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
WITCH HAZEL (UNII: 101I4J0U34)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURAMINOPROPIONATE (UNII: X5NJA9HXPU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43333-453-16	500 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	06/25/2015

Labeler - Tonic Bath and Body Products Shenzhen Ltd. (528197042)

Establishment
Name	Address	ID/FEI	Business Operations
Tonic Bath and Body Products Shenzhen Ltd.		528197042	manufacture(43333-453)