SHIELDPLEX- benzalkonium chloride lotion

Shieldplex by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

0.10% Benzalkonium Chloride

PURPOSE

Indications

Eliminates bacteria, sanitizes and moistens hands.

Warnings

For external use only.
When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions for use

Apply lotion on hands and rub vigorously for at least 30 seconds.

Inactive ingredients

Aqua/Eau/Water, Glyceryl Stearate, PEG-100 Stearate, Glycerin , Cetyl alcohol, Caprylic/Capric Triglycerides, lea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil , Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Matricaria recutita (Chamomile) Extract, Lavandula Angustifolia, Ascorbic Acid (Vitamin C), Sodium Polyacrylate, C13-14 Isoparaffin, Laureth-7, Allantoin, Disodium EDTA, Dimethicone, Panthenol, Phenoxyethanol.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SHIELDPLEX 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75490-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
OLIVE OIL (UNII: 6UYK2W1W1E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CHAMOMILE (UNII: FGL3685T2X)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75490-002-01	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2020

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

Labeler - CLT Logistics Inc. (243174344)