ULTRACRUZ ANTIBACTERIAL HAND NONE- benzalkonium chloride soap

Ultracruz Antibacterial Hand by

Drug Labeling and Warnings

Ultracruz Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by Cixi Zhixin Bird Clean-care Product Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49877-012
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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)

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