SHIELDPLEX- benzalkonium chloride lotion
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

0.10% Benzalkonium Chloride

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. 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

Label

SHIELDPLEX
benzalkonium chloride lotion

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75490-002-01	236 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)