Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ANTIBACTERIAL HAND POLAR MINT- 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

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

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 POLAR MINT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-628
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-628-01	29 mL in 1 TUBE; Type 0: Not a Combination Product	09/03/2010	09/03/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/03/2010	09/03/2012

Labeler - SJ Creations, Inc. (146379495)

Revised: 6/2019

Document Id: 8aaab958-b074-f3a3-e053-2a95a90af6f5

34390-5

Set id: 12c2cfc5-43e7-4f12-bded-8050cd939db5

Version: 5

Effective Time: 20190606