SHIELDPLEX- benzalkonium chloride liquid

Shieldplex by

Drug Labeling and Warnings

Shieldplex by is a Otc medication manufactured, distributed, or labeled by CLT Logistics Inc., Total Body Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

   Antiseptic skin cleanser 

Uses

Antiseptic (skin) cleanser Medicated (skin) cleanser Antibacterial (skin) cleanser Kills 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.

KEEP OUT OF REACH OF CHILDREN

Directions

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

Inactive ingredients

Aqua (Water), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycol Stearate, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Citric Acid, Aloe Vera Leaf Juice , Tocopheryl Acetate, Matricaria recutita (Chamomile) Extract

QUESTIONS

Package display label

INGREDIENTS AND APPEARANCE

SHIELDPLEX 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75490-001
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)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCOL STEARATE (UNII: 0324G66D0E)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75490-001-01	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/16/2020

Labeler - CLT Logistics Inc. (243174344)

Establishment
Name	Address	ID/FEI	Business Operations
Total Body Care Inc		250919615	manufacture(75490-001)