Ecological Hand Sanitizer

Ecological Hand Sanitizer by

Drug Labeling and Warnings

Ecological Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by AMENI GROUP S A S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECOLOGICAL HAND SANITIZER- alcohol gel 
AMENI GROUP S A S

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 Hand Sanitizer

Drug Facts

Active ingredient (v/v)

Ethyl Alcohol 70.0 %

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, Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Parfum (Fragrance), Aloe Barbadensis Leaf Extract, Avena Sativa Kernal Extract, PEG-40 Hydrogenated Castor Oil, Tocopherol Acetate.

Questions? 1-800-668-1483

Package Labeling: 30ml

Package Labeling: 60ml

Package Labeling: 120ml

Package Labeling: 300ml

Package Labeling: 500ml

Package Labeling: 1000ml

Package Labeling: 3700ml

ECOLOGICAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74816-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74816-002-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020	03/31/2022
2	NDC: 74816-002-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020	03/31/2022
3	NDC: 74816-002-12	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020	03/31/2022
4	NDC: 74816-002-31	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020	03/31/2022
5	NDC: 74816-002-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020	03/31/2022
6	NDC: 74816-002-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020	03/31/2022
7	NDC: 74816-002-37	3700 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020	03/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2020	03/31/2022

Labeler - AMENI GROUP S A S (885162108)

Establishment
Name	Address	ID/FEI	Business Operations
AMENI GROUP S A S		885162108	manufacture(74816-002) , label(74816-002) , pack(74816-002)

Revised: 9/2021

Document Id: cc1fb147-b43e-4a3b-e053-2a95a90a1ed6

34390-5

Set id: aa2373ac-7d3e-4922-8949-546ec6550457

Version: 2

Effective Time: 20210916