Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

SPOOKY PUMPKIN ANTIBACTERIAL HAND MOISTURIZER- 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% (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

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.

DIST. BY SJ CREATIONS, INC. P.O. BOX 232428

LEUCADIA, CA 92023, U.S.A. (888)942-2280

WWW.SJCREATIONSINC.COM . PRODUCT OF CHINA

SPOOKY PUMPKIN ANTIBACTERIAL HAND MOISTURIZER 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-887
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOPHENONE-5 (UNII: 853Z42ZYAS)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PANTHENOL (UNII: WV9CM0O67Z)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHEAT GERM OIL (UNII: 14C97E680P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-887-01	29 mL in 1 TUBE; Type 0: Not a Combination Product	08/02/2013	08/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/02/2013	08/02/2015

Labeler - SJ Creations, Inc. (146379495)

Revised: 5/2019

Document Id: 8a0c681d-ea94-6350-e053-2995a90a0679

34390-5

Set id: f254163c-8b99-4e42-b41b-33adf58c7345

Version: 8

Effective Time: 20190529