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Cetaphil® PRO (Cream, Foam, Lotion) Instructions for Use

Therapeutic Category

Cosmetic product for the care of dry and atopic skin

Properties

Cetaphil® PRO products for dry and atopic skin prone to atopic dermatitis help break the itch-scratch cycle. All products in the series are based on three levels of evidence: clinical data, instrumental study data, and patient-reported outcomes.

Clinically proven restoration of the protective barrier of skin prone to atopic dermatitis1-4

  • Skin hydration for 24 hours1;
  • Skin moisturization and moisture retention due to a unique combination of a patented ceramide and filaggrin complex5,6.

Scope of Application

Of Cetaphil® PRO product

  • For intensive moisturization and restoration of the skin barrier of dry and atopic skin.

ICD codes

ICD-10 code Indication
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
R23.8 Other and unspecified skin changes
ICD-11 code Indication
9A06.70 Atopic eczema of the eyelids
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA85.20 Atopic hand eczema
EG00 Dilation of skin vessels of the extremities
ME64 Nonspecific cutaneous vascular signs

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Cream

The cream is applied to the cleansed dry skin of the face 2 times/day, avoiding the eye area.

When used with external medicinal products, a 20-40 minute interval between applications must be observed.

Contraindications

  • Individual intolerance to the components.

Special Instructions

If any irritations or allergic reactions occur, discontinue use of the cream immediately.

Foam

The foam is recommended to be used 2 times/day, in the morning and evening, before applying moisturizing cream/medicinal product for acne therapy. The product requires rinsing with water.

Contraindications

No contraindications have been established.

Lotion

The lotion is applied in the morning and immediately after bathing. If necessary (increased dryness, in cold weather, exacerbation of atopic dermatitis, etc.), the frequency of application can be increased.

To achieve maximum effect, it is recommended to use in conjunction with Cetaphil® PRO Soothing Shower Cream-Gel.

Contraindications

  • Individual intolerance to the components.

Special Instructions

Avoid contact with eyes.

Storage Conditions

Standard storage conditions.

Shelf Life

The shelf life is indicated on the packaging.

1 Galderma. Data on file (RD.06.SPR.18164).

2 Galderma. Data on file (GLI.04.SRE.US10154).

3 Galderma. Data on file (RD.03.SPR.40066).

4 Galderma. Data on file (RD.06.SPR.18163).

5 Galderma. Data on file (RD.03.SPR.18153).

6 Galderma. Formulation claim.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Galderma, LLC (Russia)

Manufactured By

G Production, Inc. (Canada)

Contact Information

GALDERMA SA (Switzerland)

Dosage Form

Bottle OTC Icon Cetaphil® PRO Sebum-regulating moisturizing cream: bottle 118 ml with dispenser

Dosage Form, Packaging, and Product Composition

Sebum-regulating moisturizing cream

Composition water, octocrylene, isopropyl lauryl sarcosinate, glycerin, ethylhexyl salicylate, butyl methoxydibenzoylmethane, dimethicone, diisopropyl sebacate, polymethyl methacrylate, silica, aluminum starch octenylsuccinate, sucrose tristearate, dimethicone and dimethiconol, pentylene glycol, polysorbate 61, sodium stearoyl glutamate, phenoxyethanol, tocopheryl acetate, caprylyl glycol, glycyrrhetinic acid, panthenol, potassium sorbate, allantoin, zinc gluconate, xanthan gum, carbomer, triethanolamine, disodium EDTA, hydroxypalmitoyl sphinganine (ceramide-5).

118 ml – plastic bottles with a dispenser.

Marketing Authorization Holder

Galderma, LLC (Russia)

Manufactured By

G Production, Inc. (Canada)

Contact Information

GALDERMA SA (Switzerland)

Dosage Form

Bottle OTC Icon Cetaphil® PRO Mattifying cleansing foam: bottle 235 ml with dispenser

Dosage Form, Packaging, and Product Composition

Mattifying cleansing foam

Composition water, zinc coceth sulfate, glycerin, PEG-75, amyl cinnamal, benzyl benzoate, citronellol, dipotassium glycyrrhizinate, disodium EDTA, geraniol, hydroxycitronellal, linalool, PEG-7 glyceryl cocoate, PEG-40 hydrogenated castor oil, PEG-200 hydrogenated glyceryl palmitate, sodium benzoate, zinc gluconate, fragrance.

235 ml – plastic bottles with a dispenser.

Marketing Authorization Holder

Galderma, LLC (Russia)

Manufactured By

G Production, Inc. (Canada)

Contact Information

GALDERMA SA (Switzerland)

Dosage Form

Bottle OTC Icon Cetaphil® PRO Soothing day cream: bottle 50 ml with dispenser

Dosage Form, Packaging, and Product Composition

Soothing day cream

Composition water, dimethicone, titanium dioxide [nano], caprylyl methicone, zinc oxide [nano], cetyl diglyceryl tris(trimethylsiloxy)silylethyl dimethicone, glycerin, C12-15 alkyl benzoate, isohexadecane, dicaprylyl carbonate, silica, allantoin, benzyl alcohol, caffeine, chromium oxide green (CI 77288), iron oxide red (CI 77491), iron oxide yellow (CI 77492), iron oxide black (CI 77499), dipotassium glycyrrhizinate, ethylhexylglycerin, hydrogenated lecithin, magnesium sulfate, methylpropanediol, tocopherol, triethoxycaprylylsilane, trisiloxane.

50 ml – plastic bottles with a dispenser.

Marketing Authorization Holder

Galderma, LLC (Russia)

Manufactured By

G Production, Inc. (Canada)

Contact Information

GALDERMA SA (Switzerland)

Dosage Form

Bottle OTC Icon Cetaphil® PRO Night moisturizing restorative cream: bottle 50 ml with dispenser

Dosage Form, Packaging, and Product Composition

Night moisturizing restorative cream

Composition water, caprylic/capric triglyceride, glycerin, propanediol, pentylene glycol, sunflower seed oil, sorbitol, dimethicone, shea butter, cetearyl alcohol, behenyl alcohol, glyceryl stearate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, butylated hydroxytoluene, caffeine, caprylyl glycol, ceramide NP, ceteareth-20, cetyl alcohol, citric acid, dipotassium glycyrrhizinate, disodium EDTA, disodium ethylene dicocamide PEG-15 disulfate, glyceryl stearate citrate, niacinamide, panthenol, sodium hyaluronate, sodium hydroxide, xanthan gum.

50 ml – plastic bottles with a dispenser.

Marketing Authorization Holder

Galderma, LLC (Russia)

Manufactured By

G Production, Inc. (Canada)

Contact Information

GALDERMA SA (Switzerland)

Dosage Form

Bottle OTC Icon Cetaphil® PRO Soothing washing foam: bottle 236 ml with dispenser

Dosage Form, Packaging, and Product Composition

Soothing washing foam

Composition water, glycerin, sodium cocoyl glutamate, sodium cocoamphoacetate, sodium benzoate, PEG-75, allantoin, amyl cinnamal, caffeine, citric acid, citronellol, dipotassium glycyrrhizinate, disodium EDTA, geraniol, hydroxycitronellal, linalool, fragrance, PEG-40 hydrogenated castor oil, propylene glycol.

236 ml – plastic bottles with a dispenser.

Marketing Authorization Holder

Galderma, LLC (Russia)

Manufactured By

G Production, Inc. (Canada)

Contact Information

GALDERMA SA (Switzerland)

Dosage Form

Bottle OTC Icon Cetaphil® PRO Soothing shower cream-gel: bottle 295 ml

Dosage Form, Packaging, and Product Composition

Soothing shower cream-gel

Composition water, sodium polyoxyethylene tridecyl sulfate, shea butter, sunflower seed oil, glycerin, sodium lauroamphoacetate, monoethanolamine cocamide, sodium chloride, allantoin, arginine, caprylyl glycol, citric acid, disodium EDTA, guar hydroxypropyltrimonium chloride, 1,2-hexanediol, niacinamide, potassium sorbate, sodium pyrrolidone carboxylate, tocopheryl acetate.

295 ml – plastic bottles.

Marketing Authorization Holder

Galderma, LLC (Russia)

Manufactured By

G Production, Inc. (Canada)

Contact Information

GALDERMA SA (Switzerland)

Dosage Form

Bottle OTC Icon Cetaphil® PRO Skin-restoring moisturizing lotion: bottle 295 ml with dispenser

Dosage Form, Packaging, and Product Composition

Skin-restoring moisturizing lotion

Composition water, glycerin, caprylic/capric triglyceride, sunflower seed oil, pentylene glycol, shea butter, cyclopentasiloxane, cetearyl alcohol, sorbitol, behenyl alcohol, glyceryl stearate, allantoin, arginine, caprylyl glycol, ceteareth-20, cetyl alcohol, citric acid, dimethicone, disodium EDTA, disodium ethylene dicocamide PEG-15 disulfate, glyceryl stearate citrate, hydroxypalmitoyl sphinganine, niacinamide, panthenol, sodium hyaluronate, sodium pyrrolidone carboxylate, sodium polyacrylate, tocopheryl acetate.

295 ml – plastic bottles with a dispenser.

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