ANTIBACTERIAL FOAMING HAND WASH - benzalkonium chloride liquid
Tonic Bath and Body Products Shenzhen Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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, Cocamidopropylamine Oxide, Cocamidopropyl Betaine, Water, Disodium EDTA, Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, Olea Europaea (Olive) Leaf Extract, Polyaminopropyl Biguanide, Propylene Glycol, Sodium Lauroamphoacetate, Thymus Vulgaris (Thyme Oil).

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ANTIBACTERIAL FOAMING HAND WASH
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43333-450
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OXYBENZONE (UNII: 95OOS7VE0Y)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
THYMUS VULGARIS LEAF (UNII: GRX3499643)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43333-450-06	200 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/17/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
Tonic Bath and Body Products Shenzhen Ltd.		528197042	manufacture(43333-450)