Envio 90 Day Daily Essentials Trio Sub Shipment
FDA Label NDC 81252-2001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smart Skin Health, Llc for the product Envio 90 Day Daily Essentials Trio Sub Shipment (NDC 81252-2001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, use, warnings, when using this product, do not use if you, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Do Not Use If You

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Questions?

→ Principal Display Panel - Kit Carton

→ Principal Display Panel - 133 Ml Tube Label

→ Principal Display Panel - 48 G Tube Label

Other

B.P.O. Cleanser

Drug Facts

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

S.A. Serum

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

Warnings

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