Shieldplex Hand Wash by CLT Logistics, Inc / Total Body Care Inc

Shieldplex Hand Wash by

Drug Labeling and Warnings

Shieldplex Hand Wash 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]

SHIELDPLEX 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

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.

Product label

SHIELDPLEX HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75490-005
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 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75490-005-01	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020	11/30/2022
2	NDC: 75490-005-02	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020	11/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020	11/30/2022

Labeler - CLT Logistics, Inc (243174344)

Establishment
Name	Address	ID/FEI	Business Operations
Total Body Care Inc		250919615	manufacture(75490-005)

Revised: 6/2022

Document Id: e283d2e3-5fca-1d1a-e053-2a95a90a7732

34390-5

Set id: 3da672fa-86bd-4618-b388-68f560a38ca3

Version: 4

Effective Time: 20220628