ECOLOGICAL ALCOHOL FREE HAND SANITIZER- benzalkonium chloride gel
HUNTER AMENITIES INTL. LTD

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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Ecological Alcohol Free Hand Sanitizer

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 centre 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, Propylene Glycol, Glycerin, Hydroxyethylcellulose, Phenoxyethanol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice

Questions?

1-800-668-1483

Package Labeling:

Label Label2

Package Labeling:30 ml

Bottle

Package Labeling:50 ml

Bottle2

Package Labeling:120 ml

Bottle3

Package Labeling:3700 ml

Bottle4

Package Labeling:300 ml

Bottle5

Package Labeling:650 ml

Bottle6

ECOLOGICAL ALCOHOL FREE HAND SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65910-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65910-005-01	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020	06/30/2020
2	NDC:65910-005-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020	06/30/2020
3	NDC:65910-005-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020	06/30/2021
4	NDC:65910-005-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020	06/30/2020
5	NDC:65910-005-05	3700 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020	06/30/2020
6	NDC:65910-005-06	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020	06/30/2021
7	NDC:65910-005-07	650 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020	06/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2020	06/30/2021

Labeler - HUNTER AMENITIES INTL. LTD (244071015)

Revised: 10/2021

Document Id: cdb28cb7-4931-04b6-e053-2995a90a6291

Set id: 11f4ccfa-e312-49cc-8541-9d15be09c141

Version: 4

Effective Time: 20211006

HUNTER AMENITIES INTL. LTD