FDA Label for Envio 90 Day Daily Essentials Trio

View Indications, Usage & Precautions

Envio 90 Day Daily Essentials Trio Product Label

The following document was submitted to the FDA by the labeler of this product Smart Skin Health, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Dist. By: Smart Skin Health, LLC, Naples, FL 34108

Drug Facts

Dist. By: Smart Skin Health, LLC, Naples, FL 34108


Active Ingredients



Benzoyl Peroxide 5%

Salicylic Acid 2%


Purpose



Acne Treatment Gel

Acne Gel Treatment


Use



for the management of acne

for the management of acne


Warnings



For external use only

For external use only


When Using This Product



  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips, and mouth
    • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Do Not Use If You



  • have very sensitive skin
  • are sensitive to benzoyl peroxide
    • have very sensitive skin
    • are sensitive to Salicylic Acid

Stop Use And Ask A Doctor



  • if irritation becomes severe

Keep Out Of Reach Of Children



  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • apply a small amount to dampened skin
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product
  • if irritation or sensitivity develops, stop use of both products and ask a doctor. Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
    • apply evenly to affected area and allow to dry completely
    • Can be used twice daily or as directed by a doctor
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
    • if irritation or sensitivity develops, stop use of both products and ask a doctor. Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients



Water, Sodium C14-16 Olefin Sulfonate, Glycerin, Acrylates Copolymer, Cocamidopropyl Betaine, Cetearyl Alcohol, Glycol Distearate, Cetyl Alcohol, Panthenol, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Allantoin, Ethylhexylglycerin, Phenoxyethanol, Sodium Hydroxide

Water, Hydroxypropyl Starch Phosphate, Glycerin, Decyl Glucoside, Hamamelis Virginiana (Witch Hazel) Bark Extract, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Allantoin, Panthenol, Xanthan Gum, Glyceryl Stearate, Glyceryl Stearate Citrate, Lavandula Hybrida (Lavender Grosso) Oil

Certified Organic Ingredients

, Salix Alba (Willow) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Ethylhexylglycerin, Phenoxyethanol


Other Information



Protect this product from excessive heat and direct sun.

Protect this product from excessive heat and direct sun.


Questions Or Comments



Toll Free within USA 833-93-ENVIO


Otc - Stop Use



Stop use and ask a doctor if irritation becomes severe


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Questions?



Toll Free within USA 833-93-ENVIO


Principal Display Panel - Kit Carton



envio


Principal Display Panel - 133 Ml Tube Label



envio™
skin

B.P.O. 5% CLEANSER
Benzoyl Peroxide Acne Treatment
4.5 fl. oz./133 mL


Principal Display Panel - 48 G Tube Label



envio™
skin

S.A. 2% GEL SERUM
Salicylic Acid Acne Treatment
1.7 oz/48 g


* Please review the disclaimer below.