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

Label1

Package Labeling: 60ml

Label2

Package Labeling: 120ml

Label3

Package Labeling: 300ml

Label4

Package Labeling: 500ml

Label5

Package Labeling: 1000ml

Label6

Package Labeling: 3700ml

Bottle7

ECOLOGICAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74816-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74816-002-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202003/31/2022
2NDC: 74816-002-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202003/31/2022
3NDC: 74816-002-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202003/31/2022
4NDC: 74816-002-31300 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202003/31/2022
5NDC: 74816-002-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202003/31/2022
6NDC: 74816-002-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202003/31/2022
7NDC: 74816-002-373700 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202003/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/202003/31/2022
Labeler - AMENI GROUP S A S (885162108)
Establishment
NameAddressID/FEIBusiness Operations
AMENI GROUP S A S885162108manufacture(74816-002) , label(74816-002) , pack(74816-002)

Revised: 9/2021
 

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