SHIELDPLEX- 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

Use

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, Sodium Chloride, Glycol Distearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Matricaria recutita (Chamomile) Extract, Parfum, Methylchloroisothiazolinone (and) Methylisothiazolinone, Citric Acid.

Package Label - Principal Display Panel

Label 1

Label 2

SHIELDPLEX
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75490-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 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
Packaging
1	NDC:75490-006-01	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020
2	NDC:75490-006-02	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/03/2020

Labeler - CLT Logistics, Inc (243174344)