ECOSSENTIAL HAND SANITIZER- benzalkonium chloride lotion

Ecossential Hand Sanitizer by

Drug Labeling and Warnings

Ecossential Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hunter Amenities International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (v/v).

Benzalkonium Chloride 0.13 %

Purpose

Antiseptic skin cleanser

Uses

• Antiseptic (skin) cleanser
• Medicated (skin) cleanser
• Antibacterial (skin) cleanser
• Kills 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.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask/ consult a doctor

physician/ health care practitioner/ health care provider/ health care professional if irritation develops.

Keep out of reach of children.

If swallowed, call a Poison Control Center or get medical help right away.

Directions

Adults and children over 2 years:

• For occasional and personal domestic use.
• Supervise children when they use this product.
• Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Inactive ingredients

Aqua/Water/Eau, Cetearyl Alcohol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Polysorbate 60, Dimethicone, Behentrimonium Methosulfate, Phenoxyethanol, Parfum (Fragrance), Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Soy Protein, Tocopheryl Acetate, Disodium EDTA, Ethylhexylglycerin, Butylphenyl Methylpropional, Hexyl Cinnamal, Linalool, Benzyl Salicylate, Alpha-Isomethyl Ionone, Canola Oil, Citronellol, Geraniol, Limonene, Aloe Barbadensis Leaf Juice

Questions?

1-800-668-1483

Package Labeling:

Package Labeling:50ml

Package Labeling:250ml

INGREDIENTS AND APPEARANCE

ECOSSENTIAL HAND SANITIZER 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65910-014
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
CANOLA OIL (UNII: 331KBJ17RK)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHICONE (UNII: 92RU3N3Y1O)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
JOJOBA OIL (UNII: 724GKU717M)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65910-014-60	60 mL in 1 PACKAGE; Type 0: Not a Combination Product	08/11/2020	08/11/2020
2	NDC: 65910-014-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2020
3	NDC: 65910-014-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2020

Labeler - Hunter Amenities International Limited (244071015)

Establishment
Name	Address	ID/FEI	Business Operations
Hunter Amenities International Limited		244071015	manufacture(65910-014) , label(65910-014)