Pumpkin Anti-Bacterial Foaming Hand Wash (Benzethonium Chloride) Liquid [Tonic Bath And Body Products Shenzhen Ltd.] -

PUMPKIN ANTI-BACTERIAL FOAMING HAND WASH (BENZETHONIUM CHLORIDE) LIQUID [TONIC BATH AND BODY PRODUCTS SHENZHEN LTD.]
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NDC	43333-441-10
Set ID	66a0b3a6-2793-4eca-a537-904397ef28e9
Category	HUMAN OTC DRUG LABEL
Packager	Tonic Bath and Body Products Shenzhen Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333E

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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

PUMPKIN ANTI-BACTERIAL FOAMING HAND WASH
benzethonium chloride liquid

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
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43333-441-10	296 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	07/24/2014

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(43333-441)

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