GUARDEX SANITIZING HAND- benzalkonium chloride lotion

GUARDEX SANITIZING HAND by

Drug Labeling and Warnings

GUARDEX SANITIZING HAND by is a Otc medication manufactured, distributed, or labeled by Nile Hudson LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.095%

Purpose

Antiseptic

Uses

For hand cleaning reduce bacteria that potentially can cause disease and moisture your hands.

Warnings

For external use only

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

• Do not store above 105 °F
• May discolor some fabrics

Inactive Ingredients

Water, Caprylic/Capric Glycerides, Ethylhexyl Palmitate, Ammonium Polyacrylate, C13-C16 Isoparaffin, Laurath-30, Phenoxyethanol, Butyrospermum Parkii (Shea Butter), Cetearyl Alcohol, Fragrance, Panthenol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Maltodextrin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUARDEX SANITIZING HAND 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81353-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.95 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURETH-30 (UNII: W9D845551A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PANTHENOL (UNII: WV9CM0O67Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81353-126-01	76.89 mL in 1 TUBE; Type 0: Not a Combination Product	12/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/26/2020

Labeler - Nile Hudson LLC (129371101)