NOURISHING HAND SANITIZING- benzalkonium chloride insert, extended release 
United States Mask LLC

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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Nourishing Hand Sanitizing Lotion

Drug Facts

Active Ingredient

Purpose

Benzalkonium chloride 0.13%.............................................Antiseptic

Uses

Hand sanitizing and to decrease bacteria on the skin

Warnings

• For external use only

Do not use in the eyes.

• In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

• if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

• Instruct children on proper use. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

Apply small amount to hands and rub until dry. Lotion does not replace soap and water.

Other Information

Store between 15-30°C (59-86°F). Avoid Freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Starch, Behentrimonium Methosulfate, Caprylyl Glycol, Cetearyl Alcohol, Cetrimonium Chloride, Dimethicone, Glycerin, Hydrolyzed Soy Protein, Mentha Piperita (Peppermint) Essential Oil, Phenoxyethanol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Vitamin A Palmitate, Vitamin E Acetate, Water.

PRINCIPAL DISPLAY PANEL

Nourishing
Hand
Sanitizing
Lotion

100 ml/ 3.4 oz

PRINCIPAL DISPLAY PANEL
Nourishing
Hand
Sanitizing
Lotion
100 ml/ 3.4 oz

NOURISHING HAND SANITIZING 
benzalkonium chloride insert, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82289-1836
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STARCH, OAT (UNII: 904CE6697V)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
JOJOBA OIL (UNII: 724GKU717M)  
EDETATE SODIUM (UNII: MP1J8420LU)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82289-1836-1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/01/2021
Labeler - United States Mask LLC (117771858)

Revised: 10/2021
Document Id: f230cb74-b5c0-4819-bc93-414007625412
Set id: b2e73e45-d9b0-4cb5-880d-3c22fb6e17f2
Version: 1
Effective Time: 20211001
 
United States Mask LLC