SHIELDPLEX ANTIBACTERIAL HAND WASH- benzalkonium chloride soap
CLT Logistics 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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Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic skin cleanser

Uses

Antiseptic (skin) cleanser.
Medicated (skin) cleanser.
Antibacterial (skin) cleanser.
Eliminates harmful bacteria/germs.
Effective in destroying (harmful) bacteria to provide antiseptic cleansing.
For personal hand hygiene to help prevent the spread of bacteria.

Warnings

For external use only. In case of contact with eyes, rinse eyes thoroughly with water.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Lather in hands with water for at least 30 seconds. Rinse well.

Inactive ingredients

Aqua/Eau/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycol Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Citric Acid, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Matricaria recutita (Chamomile) Extract, Parfum (Fragrance).

Package Label - Principal Display Panel

Label

SHIELDPLEX ANTIBACTERIAL HAND WASH
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75490-004
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMOMILE (UNII: FGL3685T2X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75490-004-01	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/12/2020

Labeler - CLT Logistics Inc. (243174344)