Ultracruz Antibacterial Hand None (Benzalkonium Chloride) Soap [Cixi Zhixin Bird Clean-Care Product Co., Ltd.] -

ULTRACRUZ ANTIBACTERIAL HAND NONE (BENZALKONIUM CHLORIDE) SOAP [CIXI ZHIXIN BIRD CLEAN-CARE PRODUCT CO., LTD.]
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NDC	49877-012-01
Set ID	ed390aba-247e-486c-9979-a9863a5b4269
Category	HUMAN OTC DRUG LABEL
Packager	Cixi Zhixin Bird Clean-care Product Co., Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333A

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ACTIVE INGREDIENT

Active Ingredient:

Benzalkonium Chloride 0.1%
PURPOSE

Purpose:

Antiseptic
INDICATIONS & USAGE

Uses:

For hand washing to kill bacterial on the skin
WARNINGS

Warnings

For external use only

Flammable. Keep away from fire or flame

Do not apply around eyes. Do not use in ears & mouth

When using this product, avoid contatc with eyes. In case of contact, flush eyes with water
STOP USE

Stop use and see a doctor if irritation or redness develop and persist for more than 72 hours
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Children must be supervised in use of this product.
DOSAGE & ADMINISTRATION

Directions:

Wet hands, apply to palms, scrub thoroughly, then rinse.
OTHER SAFETY INFORMATION

Other Information:

Store at 20C (68-77F). May discolor fabrics
INACTIVE INGREDIENT

Inactive Ingredient:

Deionized water, Sodium lauryl polyoxyehthylene ether sulfate, Sodium fatty alcohol ethyl sulfate, Cocoamidoprophyl

betaine, Carboxylmethylcellulose sodium, DMDM Hydantoin, Glycerol, Frangance
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRACRUZ ANTIBACTERIAL HAND NONE
benzalkonium chloride soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	72.525 g in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49877-012-01	237 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/22/2014

Labeler - Cixi Zhixin Bird Clean-care Product Co., Ltd. (529823986)

Registrant - Cixi Zhixin Bird Clean-care Product Co., Ltd. (529823986)

Name	Address	ID/FEI	Business Operations
Establishment
Cixi Zhixin Bird Clean-care Product Co., Ltd.		529823986	manufacture(49877-012)

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