Label: ENVIO 90 DAY DAILY ESSENTIALS DUO- benzoyl peroxide and salicylic acid kit

  • NDC Code(s): 81252-0102-1, 81252-0202-1, 81252-1002-1
  • Packager: Smart Skin Health, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 6, 2023

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  • SPL UNCLASSIFIED SECTION

    B.P.O. Cleanser

    Drug Facts

  • Active Ingredients

    Benzoyl Peroxide 5%

  • Purpose

    Acne Treatment Gel

  • 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.

    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.
  • 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.
  • 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

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments

    Toll Free within USA 833-93-ENVIO

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    S.A. Serum

    Drug Facts

  • Active Ingredients

    Salicylic Acid 2%

  • Purpose

    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.

    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.

  • 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.
  • Inactive Ingredients

    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) Oil1, Salix Alba (Willow) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract1, Ethylhexylglycerin, Phenoxyethanol

    1
    Certified Organic Ingredients
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions?

    Toll Free within USA 833-93-ENVIO

  • SPL UNCLASSIFIED SECTION

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

  • 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 /4 8 g

    PRINCIPAL DISPLAY PANEL - 48 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ENVIO 90 DAY DAILY ESSENTIALS DUO 
    benzoyl peroxide and salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81252-1002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81252-1002-11 in 1 CARTON10/21/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 133 mL
    Part 21 TUBE 48 g
    Part 31 TUBE 30 g
    Part 1 of 3
    B.P.O. CLEANSER 
    benzoyl peroxide gel
    Product Information
    Item Code (Source)NDC:81252-0102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Glycol Distearate (UNII: 13W7MDN21W)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Panthenol (UNII: WV9CM0O67Z)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Allantoin (UNII: 344S277G0Z)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81252-0102-1133 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D10/21/2021
    Part 2 of 3
    S.A. SERUM 
    salicylic acid gel
    Product Information
    Item Code (Source)NDC:81252-0202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    Witch Hazel (UNII: 101I4J0U34)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Allantoin (UNII: 344S277G0Z)  
    Panthenol (UNII: WV9CM0O67Z)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Glyceryl Stearate Citrate (UNII: WH8T92A065)  
    Salix Alba Bark (UNII: 205MXS71H7)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81252-0202-148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D10/21/2021
    Part 3 of 3
    CLARIFYING CLAY MASK 
    paste masks (mud packs) paste
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRBentonite (UNII: A3N5ZCN45C)  
    INGRKaolin (UNII: 24H4NWX5CO)  
    INGRGlyceryl Ricinoleate (UNII: ZUE0CEL42O)  
    INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
    INGRStearic Acid (UNII: 4ELV7Z65AP)  
    INGRAlcohol (UNII: 3K9958V90M)  
    INGRCetyl Alcohol (UNII: 936JST6JCN)  
    INGRTitanium Dioxide (UNII: 15FIX9V2JP)  
    INGRCranberry (UNII: 0MVO31Q3QS)  
    INGRSalix Alba Bark (UNII: 205MXS71H7)  
    INGRPassiflora Incarnata Flower (UNII: K8F3G29S6Z)  
    INGRChamomile (UNII: FGL3685T2X)  
    INGRCalendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    INGRRosemary Oil (UNII: 8LGU7VM393)  
    INGRLonicera Japonica Flower (UNII: 4465L2WS4Y)  
    INGRLonicera Caprifolium Flower (UNII: 5N1WD9784U)  
    INGR.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)  
    INGRAllantoin (UNII: 344S277G0Z)  
    INGRGlycol Distearate (UNII: 13W7MDN21W)  
    INGRGlyceryl Monostearate (UNII: 230OU9XXE4)  
    INGRCocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRCaprylyl Glycol (UNII: 00YIU5438U)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGRFytic Acid (UNII: 7IGF0S7R8I)  
    INGRMaltodextrin (UNII: 7CVR7L4A2D)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGRTrisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    INGRCarbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC10/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/21/2021
    Labeler - Smart Skin Health, LLC (117039871)
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