COVID-19: March 27 Hydroalcoholic Gel Formula
Formulations conforming to one of the following 4 formulas are authorized by way of derogation by this order.
Source: https://www.legifrance.gouv.fr/eli/arrete/2020/3/27/TREP2008649A/jo/texte
FORMULA/COMPOSITION NO 1
Making up | Amount | Function | Repository |
|---|---|---|---|
Ethanol at 98.7 percent V/V minimum | 810.5mL | Active substance | European Pharmacopoeia or suppliers listed on the European Chemicals Agency website (1) or ethyl alcohol of agricultural origin within the meaning of Annex 1 of Regulation (EC) No 110/2008 or natural ethanol produced according to standard EN 15376: 2014 |
Ethanol at 96 percent V/V WHERE | 833.3mL | ||
Ethanol at 95 percent V/V WHERE | 842.1mL | ||
Ethanol at 90 percent V/V | 888.8mL | ||
Hydrogen peroxide, 3 percent solution | 41.7mL | spore inactivator | European Pharmacopoeia or suppliers listed on the European Chemicals Agency website (1) |
Glycerol (glycerin) | 14.5mL | Humectant | European Pharmacopoeia or United States Pharmacopoeia (or USP) or Japanese Pharmacopoeia (or JP) or in accordance with article 19 paragraph 9 of Regulation (EU) n° 528/2012 |
qsp purified water Or Microbiologically clean deionized water qsp Where Distilled water qsp | 1000.0mL | Solvent | European Pharmacopoeia (for purified water only) |
(1) https://echa.europa.eu/fr/information-on-chemicals/active-substance-suppliers.
LABELING
The label says:
- the name of the solution: "Hydro-alcoholic solution recommended by the World Health Organization for hand antisepsis"
- the composition: "Ethanol - hydrogen peroxide - glycerol"
- name of the manufacturer who produced the solution
- date of manufacture and batch number
- storage conditions
- the statement: "For cutaneous application only"
- the statement: "Avoid contact with eyes"
- the statement: "Keep out of reach of children"
- the statement: "Flammable liquid: keep away from heat and any flame"
- the instructions for use: "Fill the palm of one hand with the solution and rub all the surfaces of the hands until the skin is dry"
CONSERVATION BEFORE OPENING
At room temperature (15°C to 25°C): 2 years from the date of manufacture.
BATCH RELEASE
Prior to their dispensation, the batches are quarantined for 72 hours to allow the destruction of any spores present in the alcohol.
FORMULA/COMPOSITION NO 2
Making up | Amount | Function | Repository |
|---|---|---|---|
Isopropanol 99.8% V/V | 751.5mL | Active substance | European Pharmacopoeia or suppliers listed on the European Chemicals Agency website (2) |
Hydrogen peroxide, 3 percent solution | 41.7mL | spore inactivator | European Pharmacopoeia or suppliers listed on the European Chemicals Agency website (2) |
Glycerol (glycerine) | 14.5mL | Humectant | European Pharmacopoeia or United States Pharmacopoeia (or USP) or Japanese Pharmacopoeia (or JP) or in accordance with article 19 paragraph 9 of Regulation (EU) n° 528/2012 |
qsp purified water Or Microbiologically clean deionized water qsp Where Distilled water qsp | 1000.0mL | Solvent | European Pharmacopoeia (for purified water only) |
(2) https://echa.europa.eu/en/information-on-chemicals/active-substance-suppliers.
LABELING
The label says:
- the name of the solution: "Hydro-alcoholic solution recommended by the World Health Organization for hand antisepsis"
- the composition: "isopropanol - hydrogen peroxide - glycerol"
- name of the manufacturer who produced the solution
- date of manufacture and batch number
- storage conditions
- the statement: "For cutaneous application only"
- the statement: "Avoid contact with eyes"
- the statement: "Keep out of reach of children"
- the statement: "Flammable liquid: keep away from heat and any flame"
- the instructions for use: "Fill the palm of one hand with the solution and rub all the surfaces of the hands until the skin is dry"
CONSERVATION BEFORE OPENING
At room temperature (15°C to 25°C): 2 years from the date of manufacture.
BATCH RELEASE
Prior to their dispensation, the batches are quarantined for 72 hours to allow the destruction of any spores present in the alcohol.
FORMULA/COMPOSITION NO 3
Making up | Amount | Repository |
|---|---|---|
Ethanol at 98.7 percent V/V minimum WHERE | 650 to 750mL | European Pharmacopoeia or suppliers listed on the European Chemicals Agency website (3) or ethyl alcohol of agricultural origin within the meaning of Annex 1 of Regulation (EC) No 110/2008 or natural ethanol produced according to standard EN 15376: 2014 |
Ethanol at 96 percent V/V WHERE | 675 to 777mL | |
Ethanol at 95 percent V/V WHERE | 681 to 786mL | |
Ethanol at 90 percent V/V | 720 to 830mL | |
Glycerol (glycerine) | 50mL | European Pharmacopoeia or United States Pharmacopoeia (or USP) or Japanese Pharmacopoeia (or JP) or in accordance with article 19 paragraph 9 of Regulation (EU) n° 528/2012 |
A thickening polymer chosen from: 1. CARBOMER: 1.5 to 2 ml + AMINOMETHYL PROPANEDIOL: 0.26 - 0.35 ml 2. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER: 1.5 to 2 ml + AMINOMETHYL PROPANEDIOL: 0.26 - 0.35 ml 3. WATER, ACRYLATES COPOLYMER, SODIUM LAURYL SULFATE: 50-60 ml + AMINOMETHYL PROPANEDIOL: 1 - 2 ml 4. AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER: 3.5 to 10 ml 5. HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYSORBATE 60, SORBITAN ISOSTEARATE, WATER: 10 to 20 ml 6. POLYACRYLAMIDOMETHYL PROPANE SULFONIC ACID PARTIALLY NEUTRALIZED WITH AMMONIA AND HIGHLY CROSS-LINKED 7 ml | Compliant with Article 19 paragraph 9 of Regulation (EU) No. 528/2012 | |
qsp purified water Or Microbiologically clean deionized water qsp Where Distilled water qsp | 1000.0mL | European Pharmacopoeia (for purified water only) |
(3) https://echa.europa.eu/en/information-on-chemicals/active-substance-suppliers.
LABELING
The label says:
- the name of the gel: "Hydro-alcoholic gel for hand antisepsis - derogatory decree"
- the composition: "Ethanol - Glycerin - thickening polymer used"
- name of the manufacturer who made the gel
- date of manufacture and batch number
- storage conditions
- the statement: "For cutaneous application only"
- the statement: "Avoid contact with eyes"
- the statement: "Keep out of reach of children"
- the statement: "Flammable liquid: keep away from heat and any flame"
- the instructions for use: "Fill the palm of one hand with the gel and rub all the surfaces of the hands until the skin is dry"
CONSERVATION BEFORE OPENING
At room temperature (15°C to 25°C): 2 years from the date of manufacture.
BATCH RELEASE
Immediate.
FORMULA/COMPOSITION NO 4
Making up | Amount | Repository |
|---|---|---|
Ethanol at 98.7 percent V/V minimum WHERE | 56.5% to 65.1% w/w (i.e. 65% to 75% by volume at 20°C) | European Pharmacopoeia or suppliers listed on the European Chemicals Agency website (4) or ethyl alcohol of agricultural origin within the meaning of Annex 1 of Regulation (EC) No 110/2008 or natural ethanol produced according to standard EN 15376: 2014 |
Ethanol at 96 percent V/V WHERE | 58% to 67% w/w (i.e. 65% to 75% by volume at 20°C) | |
Ethanol at 95 percent V/V WHERE | 59.1% to 68.1% w/w (i.e. 65% to 75% by volume at 20°C) | |
Ethanol at 90 percent V/V | 63.7% to 73.5% w/w (i.e. 65% to 75% by volume at 20°C) | |
Glycerol (glycerine) WHERE Propylene glycol WHERE Butylene glycol WHERE Propanediol WHERE Diglycerin | 0.5 to 5% by weight | European Pharmacopoeia or United States Pharmacopoeia (or USP) or Japanese Pharmacopoeia (or JP) or in accordance with article 19 paragraph 9 of Regulation (EU) n° 528/2012 |
Polyacrylate Crosspolymer-6 WHERE | 0.4 to 0.8% by weight | Compliant with Article 19 paragraph 9 of Regulation (EU) No. 528/2012 |
Ammonium Acryloyldimethyltaurate/VP Copolymer * WHERE | 0.4 to 1% by weight | |
Carbomer neutralized with aminomethylpropanol (AMP) or with soda or with triethanolamine WHERE | 0.2 to 1% by weight | |
Neutralized acrylate copolymer WHERE | 1 to 3% by weight | |
Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer) WHERE | 0.5 to 2% by weight | |
Acrylamide/Sodium Acryloydimethyl Taurate & Isohexadecane & Polysorbate 80) WHERE | 1 to 4% by weight | |
Acrylates/C10-C30 alkyl acrylate crosspolymer | 0.2 to 1% by weight | |
qsp purified water Or Microbiologically clean deionized water qsp Where Distilled water qsp | 100% | European Pharmacopoeia (for purified water only) |
(4) https://echa.europa.eu/en/information-on-chemicals/active-substance-suppliers.
LABELING
The label says:
- the name of the gel: "Hydro-alcoholic gel for hand antisepsis - derogatory decree"
- the composition: "Ethanol - humectant used - thickening polymer used"
- name of the manufacturer who made the gel
- date of manufacture and batch number
- storage conditions
- the statement: "For cutaneous application only"
- the statement: "Avoid contact with eyes"
- the statement: "Keep out of reach of children"
- the statement: "Flammable liquid: keep away from heat and any flame"
- the instructions for use: "Fill the palm of one hand with the gel and rub all the surfaces of the hands until the skin is dry"
CONSERVATION BEFORE OPENING
At room temperature (15°C to 25°C): 2 years from the date of manufacture.
BATCH RELEASE
Immediate.
