ULTRACRUZ ANTIBACTERIAL NONE- benzalkonium chloride lotion 
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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Ultracruz Antibacteria Lotion

Active Ingredient:

Benzalkonium Chloride 0.1%

Purpose:

Antiseptic

Uses:

Kill germs while soothing skin. Contains Vintamin E and Aloe Vera

Directions:

Aquirt as needed into your palms and thoroughly spread on both hands

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 eys 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.

Other Information:

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

Inactive Ingredient:

Deionized water, Vitamin E, Aloe vera, Glycerol, Boric acid, Carbomer, TX-20, Triethanolamine, White oil, Fragrance

label picture

ULTRACRUZ ANTIBACTERIAL  NONE
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49877-011
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) 96.105 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
GLYCEROL FORMAL (UNII: 3L7GR2604E)  
ALOE (UNII: V5VD430YW9)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
BORIC ACID (UNII: R57ZHV85D4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49877-011-01237 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(49877-011)

Revised: 8/2014
Document Id: cc0e831d-9fa0-402c-9118-393376e65734
Set id: e3111c78-df33-419a-af35-294ea586b0d8
Version: 1
Effective Time: 20140822
 
Cixi Zhixin Bird Clean-care Product Co., Ltd.