Save

Save

Save

Save

Save


Prescribing Information HylatopicPlus® Lotion

Rx Only
For Topical Dermatological and External Use Only

INDICATIONS FOR USE
Under the supervision of a healthcare professional, HylatopicPlus® Lotion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus® Lotion also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS   
HylatopicPlus® Lotion is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

WARNINGS
Use only as directed. Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

PRECAUTIONS AND OBSERVATIONS

  • HylatopicPlus® Lotion does not contain a sunscreen and should not be used prior to extended exposure to the sun.
  • If clinical signs of infection are present, appropriate treatment should be initiated; use of HylatopicPlus® Lotion may be continued during the anti-infective therapy.
  • If the condition does not improve within 10 – 14 days, consult a physician.
  • HylatopicPlus® Lotion may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE
To unlock pump, turn pump counterclockwise until it pops up. Dispense HylatopicPlus® Lotion into palm of hand and apply to affected area 3 times per day, or as directed by a physician. Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing.

INGREDIENTS
Water, Glycerin, Ethylhexyl Palmitate, Propylene Glycol, Cetearyl Alcohol, Theobroma Grandiflorum Seed Butter, Dicetyl Phosphate, Dimethicone, Petrolatum, Tocopheryl Acetate, Steareth-10, Phenoxyethanol, Ceteareth-10 Phosphate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Disodium EDTA, Sodium Hyaluronate and Sodium Hydroxide.

HOW SUPPLIED
HylatopicPlus® Lotion is available in 5g professional sample tubes (NDC 69482-200-05), and, 14 fl. oz. commercial bottle (NDC 69482-200-16).

Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.

Store between 59°F - 86°F (15°C - 30°C).

To report SUSPECTED ADVERSE REACTIONS, contact Encore Dermatology at 844-848-6543, Option 1 or AE@encorederm.com, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Prescribing Information HylatopicPlus® Cream

Rx Only
For Topical Dermatological and External Use Only

INDICATIONS FOR USE
Under the supervision of a healthcare professional, HylatopicPlus® Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus® Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS   
HylatopicPlus® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

WARNINGS
Use only as directed.  Keep out of the reach of children.  Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

PRECAUTIONS AND OBSERVATIONS

  • HylatopicPlus® Cream does not contain a sunscreen and should not be used prior to extended exposure to the sun.
  • If clinical signs of infection are present, appropriate treatment should be initiated; use of HylatopicPlus® Cream may be continued during the antiinfective therapy.
  • If the condition does not improve within 10 – 14 days, consult a physician.
  • HylatopicPlus® Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE
Dispense HylatopicPlus® Cream into palm of hand and apply to affected area 3 times per day, or as directed by a physician.

Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing.

INGREDIENTS
Water, Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Petrolatum, Theobroma Grandiflorum Seed Butter, Dimethicone, Ceteareth- 10 Phosphate, Steareth- 10, Phenoxyethanol, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Sodium Hyaluronate, Disodium EDTA and Sodium Hydroxide.

HOW SUPPLIED
HylatopicPlus® Cream is available in 3g professional sample tubes (NDC 69482-216-03), 100g commercial tubes (NDC 69482-216-96) and 450g commercial jars (69482-216-16).

Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.

Store between 59°F - 86°F (15°C - 30°C).

To report SUSPECTED ADVERSE REACTIONS, contact Encore Dermatology at 844-848-6543, Option 1 or AE@encorederm.com, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Prescribing Information HylatopicPlus® Emollient Foam

Rx Only
For Topical Dermatological and External Use Only
Do Not Use In Eyes

INDICATIONS FOR USE
Under the supervision of a healthcare professional,HylatopicPlus® Emollient Foam is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus® Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS
HylatopicPlus® is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

WARNINGS
Use only as directed. Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C). Do not apply within four hours prior to a radiation session.

PRECAUTIONS AND OBSERVATIONS

  • HylatopicPlus® Emollient Foam does not contain a sunscreen and should not be used prior to extended exposure to the sun.
  • If clinical signs of infection are present, appropriate treatment should be initiated; use of HylatopicPlus® Emollient Foam may be continued during the anti-infective therapy.
  • If the condition does not improve within 10 – 14 days, consult a physician.
  • HylatopicPlus® Emollient Foam may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE
Important: Prime Can Before Initial Use. To Prime Can:
Shake can well (until product moves inside can). Firmly strike bottom of can onto palm of hand at least 3 times. Hold can upright and direct initial spray to a nonskin surface. Until foam dispenses, DO NOT spray directly on the skin as the initial spray may expel cold, liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.
During Use: Holding can upright, dispense HylatopicPlus® Emollient Foam into palm of hand and apply to affected area 3 times per day, or as directed by a physician. Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing. Wipe off any excess foam from actuator after use.

INGREDIENTS
Water, Hydrofluorocarbon 134a, Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Petrolatum, Theobroma Grandiflorum Seed Butter, Dimethicone, Ceteareth- 10 Phosphate, Steareth- 10, Phenoxyethanol, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide.

HOW SUPPLIED
HylatopicPlus® Emollient Foam is available in 5g (NDC 69482-197-06), professional sample aluminum cans and 100g (NDC 69482-197-96) and 150g (69482-197-97) commercial aluminum cans

Will not dispense entire contents. Container is overfilled to guarantee dispensing at least the listed amount.

Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.

Store between 59°F - 86°F (15°C - 30°C). Protect from freezing. Store upright.

Patent Pending

To report SUSPECTED ADVERSE REACTIONS, contact Encore Dermatology at 844-848-6543, Option 1 or AE@encorederm.com, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save