Envio 90 Day Daily Essentials Trio Sub Shipment

Benzoyl Peroxide And Salicylic Acid


Smart Skin Health, Llc
Human Otc Drug
NDC 81252-2001
Envio 90 Day Daily Essentials Trio Sub Shipment also known as Benzoyl Peroxide And Salicylic Acid is a human otc drug labeled by 'Smart Skin Health, Llc'. National Drug Code (NDC) number for Envio 90 Day Daily Essentials Trio Sub Shipment is 81252-2001. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Envio 90 Day Daily Essentials Trio Sub Shipment drug includes . The currest status of Envio 90 Day Daily Essentials Trio Sub Shipment drug is Active.

Drug Information:

Drug NDC: 81252-2001
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Envio 90 Day Daily Essentials Trio Sub Shipment
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Benzoyl Peroxide And Salicylic Acid
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Smart Skin Health, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Kit
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 21 Oct, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 04 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part333D
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Smart Skin Health, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:308696
346298
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
81252-2001-11 KIT in 1 CARTON (81252-2001-1) * 48 g in 1 TUBE (81252-0202-1) * 45 mL in 1 TUBE * 133 mL in 1 TUBE (81252-0102-1)21 Oct, 2021N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose acne treatment gel

Purpose acne gel treatment

Product Elements:

Envio 90 day daily essentials trio sub shipment benzoyl peroxide and salicylic acid b.p.o. cleanser benzoyl peroxide benzoyl peroxide benzoyl peroxide water sodium c14-16 olefin sulfonate glycerin cocamidopropyl betaine cetostearyl alcohol glycol distearate cetyl alcohol panthenol aloe vera leaf hyaluronate sodium allantoin ethylhexylglycerin phenoxyethanol sodium hydroxide s.a. serum salicylic acid salicylic acid salicylic acid water glycerin decyl glucoside witch hazel tea tree oil allantoin panthenol xanthan gum glyceryl monostearate glyceryl stearate citrate ylang-ylang oil salix alba bark green tea leaf ethylhexylglycerin phenoxyethanol hydrator water glycerin totarol aloe vera leaf ylang-ylang oil sandalwood lavender oil camphor oil orange oil, cold pressed rosa x damascena flower oil lonicera japonica flower lonicera caprifolium flower chlorophyll hamamelis virginiana top water alcohol citric acid monohydrate maltodextrin trisodium ethylenediamine disuccinate carbomer homopolymer, unspecified type sodium hydroxide sodium metabisulfite acetyltributyl citrate phenylethyl alcohol caprylyl glycol potassium sorbate

Indications and Usage:

Use for the management of acne

Use for the management of acne

Warnings:

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. do not use if you have very sensitive skin are sensitive to benzoyl peroxide 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.

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. do not use if you 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.

Do Not Use:

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. do not use if you have very sensitive skin are sensitive to benzoyl peroxide 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.

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. do not use if you 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.

When Using:

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.

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.

Dosage and Administration:

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.

Directions 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 .

Stop Use:

Stop use and ask a doctor if irritation becomes severe

Stop use and ask a doctor if irritation becomes severe

Package Label Principal Display Panel:

Principal display panel - kit carton envio principal display panel - kit carton

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 - 133 ml tube label

Principal display panel - 48 g tube label envio™ skin s.a. 2% gel serum salicylic acid acne treatment 1.7 oz / 48 g principal display panel - 48 g tube label

Further Questions:

Questions or comments toll free within usa 833-93-envio

Questions? toll free within usa 833-93-envio


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.