ULTRACRUZ ANTIBACTERIAL HAND NONE- benzalkonium chloride soap 
Cixi Zhixin Bird Clean-care Product Co., 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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Antibacterial Hand Soap

Active Ingredient:

Benzalkonium Chloride 0.1%

Purpose:

Antiseptic

Uses:

For hand washing to kill bacterial on the skin

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 and see a doctor if irritation or redness develop and persist for more than 72 hours

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

Directions:

Wet hands, apply to palms, scrub thoroughly, then rinse.

Other Information:

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

Inactive Ingredient:

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

betaine, Carboxylmethylcellulose sodium, DMDM Hydantoin, Glycerol, Frangance

label picture

ULTRACRUZ ANTIBACTERIAL HAND  NONE
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49877-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49877-012-01237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/22/2014
Labeler - Cixi Zhixin Bird Clean-care Product Co., Ltd. (529823986)
Registrant - Cixi Zhixin Bird Clean-care Product Co., Ltd. (529823986)
Establishment
NameAddressID/FEIBusiness Operations
Cixi Zhixin Bird Clean-care Product Co., Ltd.529823986manufacture(49877-012)

Revised: 8/2014
Document Id: b163da89-3588-4aac-8c97-1e2af1479ef7
Set id: ed390aba-247e-486c-9979-a9863a5b4269
Version: 1
Effective Time: 20140822
 
Cixi Zhixin Bird Clean-care Product Co., Ltd.