SPICE ANTI-BACTERIAL FOAMING HAND WASH- benzethonium chloride liquid

Spice Anti-bacterial foaming Hand Wash by

Drug Labeling and Warnings

Spice Anti-bacterial foaming Hand Wash 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

Water (Aqua), Sodium Lauroamphoacetate, Cocomidopropylamine Oxide, Cocamidopropyl Betaine, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Olea Europaea (Olive) Leaf Extract, Fragrance (Parfume), Polyaminopropyl Biguanide, Thymus Vulgaris (Thyme) Oil, Citric Acid, Methylchloroisothiazolinone $ Methylisothiazolinone, Disodium EDTA, Benzophenone-3. May contain: FD&C Red NO. 40 (CI 16035), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090).

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPICE ANTI-BACTERIAL FOAMING HAND WASH 
benzethonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43333-444
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
WATER (UNII: 059QF0KO0R)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETIC ACID (UNII: 9G34HU7RV0)
OXYBENZONE (UNII: 95OOS7VE0Y)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	FD&C RED NO. 40 (UNII: WZB9127XOA)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43333-444-10	296 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/24/2014

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(43333-444)