Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ANTIBACTERIAL HAND GB SUGAR COOKIE- 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

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>Benzophenone-4, BHT, Cetearyl Alcohol, Deionized water(Aqua), Dimethicone, Disodium EDTA, DMDM Hyandantoin, Fragrance (Perfume),Glycerin, Glyceryl Stearate and PEG-100 Stearate, Methylparaben, Mineral Oil, Pantenol, Polyacrylamide, Polysorbate 60, Propylparaben, Tocopheryl Acetate, Triticum Vulgare(Wheat) Germ Oil.</p>

DIST. BY SJ CREATIONS, INC.

P.O. BOX 232428 LEUCADIA, CA 92024, U.S.A.

(888)942-2280 WWW.SJCREATIONSINC.COM

PRODUCT OF CHINA

ANTIBACTERIAL HAND GB SUGAR COOKIE 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-649
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, WHEAT (UNII: 79QS2MG2LP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-649-01	29 mL in 1 TUBE; Type 0: Not a Combination Product	08/24/2010	08/24/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	08/24/2010	08/24/2012

Labeler - SJ Creations, Inc. (146379495)

Revised: 6/2019

Document Id: 8aaae234-f3bf-14e8-e053-2a95a90a1914

34390-5

Set id: 71c60388-2d6d-4e82-9030-fca4d6c884c7

Version: 3

Effective Time: 20190606