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


Drug Facts

BOOLICIOUS ANTIBACTERIAL HAND  - alcohol gel 
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

Alcohol, Denatured 65% (Purpose: Antiseptic)

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from heat and flame.


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

Aminomethyl Propanol, Benzophenone-4, Carbomer, Deionized Water(Aqua), Disodium EDTA, DMDM Hyantoin, Fragrance(Perfume), Glycerin.

image of ../images_otc/boolicious_a_SJ11287BOOgel.jpg



















DIST. BY SJ CREATIONS, INC.

P.O. BOX 232428

LEUCADIA, CA 92023, U.S.A.

(888)942-2280

WWW.SJCREATIONSINC.COM

PRODUCT OF CHINA


BOOLICIOUS ANTIBACTERIAL HAND 
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43269-688
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 65 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
CARBOMER HOMOPOLYMER TYPE C  
AMINOMETHYLPROPANOL  
DMDM HYDANTOIN  
EDETATE DISODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43269-688-01 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 06/28/2011

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

Revised: 06/2011 SJ Creations, Inc.



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


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