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Name:Antibacterial Hand Mistletoe And Mint
Manufacturer:Sj Creations, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTIBACTERIAL HAND MISTLETOE AND MINT   - benzalkonium chloride lotion 
SJ Creations, Inc.

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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Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13% VOL (Purpose: Antiseptic)

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 thoroughly with product and allow to dry without wiping.

Inactive Ingredients

Benzophenone-4, BHT, Cetearyl Alcohol, Deionized water(Aqua), Dimethicone, Disodium EDTA, DMDM Hyandantoin,FD and C Blue No.1 (CI 42090), Fragrance (Perfume),Glycerin, Glyceryl Stearate and PEG-100 Stearate, Methylparaben, Mineral Oil, Pantenol, Polyacrylamide, Polysorbate 60, Propylparaben, Tocopheryl Acetate, Triticum Vulgare(Wheat) Germ Oil.

image of sj10214mtlotiontubewrap













DIST. BY SJ CREATIONS, INC.

P.O. BOX 232428 LEUCADIA, CA 92023, U.S.A.

(888)942-2280 WWW.SJCREATIONSINC.COM

PRODUCT OF CHINA


ANTIBACTERIAL HAND MISTLETOE AND MINT  
benzalkonium chloride lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43269-634
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE .13 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
MINERAL OIL  
CETOSTEARYL ALCOHOL  
DMDM HYDANTOIN  
EDETATE DISODIUM  
SULISOBENZONE  
GLYCERYL MONOSTEARATE  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)  
POLYSORBATE 60  
DIMETHICONE  
STARCH, WHEAT  
METHYLPARABEN  
PROPYLPARABEN  
PANTHENOL  
.ALPHA.-TOCOPHEROL ACETATE, D-  
BUTYLATED HYDROXYTOLUENE  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43269-634-01 29 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/03/2010

Labeler - SJ Creations, Inc. (146379495)
Establishment
Name Address ID/FEI Operations
Tonic Bath and Body Products Shenzhen Ltd. 528197042 manufacture

Revised: 09/2010 SJ Creations, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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