Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ANTIBACTERIAL FOAMING HAND WASH SWEET TREATS- benzalkonium chloride liquid 
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%

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. Apply palmful to hands and forearms. Scrub thoroughly. Rinse and repeat. Dry thoroughly.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Benzophenone-3, Citric Acid, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, , Water, Disodium EDTA, FD&C Red. No. 40 (CI16035), FD&C Yellow No. 5 (CI19140), Fragrance (Parfum), Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, Olea Europaea (Olive) Leaf Extract, Panthanol, Polysorbate 20, Propylene Glycol, Sodium Lauroamphoacetate.

ANTIBACTERIAL FOAMING HAND WASH SWEET TREATS 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-916
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 13 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OXYBENZONE (UNII: 95OOS7VE0Y)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
WITCH HAZEL (UNII: 101I4J0U34)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURAMINOPROPIONATE (UNII: X5NJA9HXPU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-916-16	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/03/2015	06/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/03/2015	06/03/2017

Labeler - SJ Creations, Inc. (146379495)

Revised: 5/2019

Document Id: 8a0b1a05-fc49-322b-e053-2a95a90a288c

34390-5

Set id: a41df618-37fe-43db-904b-18b00a5ff597

Version: 4

Effective Time: 20190529