Label: CLEAR ACNE KIT- acne kit kit

  • 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 July 6, 2020

If you are a consumer or patient please visit this version.

  • Step 1 - Acne Face CleanserDrug Facts

    Active Ingredient

    Salicylic acid 1.0%

    Purpose

    Acne Treatment

    Use

    • For the treatment of acne

    Warnings

    For external use only

    When using this product

    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

    Stop use and ask a doctor

    • If irritation persists

    Keep out of reach of children

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

    Directions

    • Wet face. Apply to hands, add water and work into lather. Gently massage all over face avoiding eye area. Rinse thoroughly and pat dry. Good for daily use.
    • Cover the entire affected area with a thin layer 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
    • For children under 10 years of age, consult your physician.

    Inactive Ingredients

    Benzyl Alcohol, Chlorphenesin, Cocamide MEA, Cocamidopropyl Betaine, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Hydrolyzed Jojoba Ester, Lauroyl Lysine, Methyl Glucose Caprate/ Caprylate/ Oleate, Myristic Acid, Propanediol, Salt (Sodium Chloride), Soapberry (Sapindus Mukurossi) Fruit Extract, Sodium Cocoyl Apple Amino Acids, Sodium Hydroxide, Sodium Lauroyl Methyl Isethionate, Sodium Methyl Cocoyl Taurate, Squalane, Stearic Acid, Tetrasodium EDTA, Trisodium Ethylenediamine Dissuccinate, Vitamin E (Tocopheryl Acetate), Water, Xanthan Gum.

    Questions or Comments?

    1-855-626-6606

  • Step 2 - Acne Spot TreatmentDrug Facts

    Active Ingredient

    Salicylic acid 2.0%

    Purpose

    Acne Treatment

    Use

    • For the treatment of acne

    Warnings

    For external use only

    When using this product

    • Avoid unnecessary sun exposure and use sunscreen.
    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

    Stop use and ask a doctor

    • If irritation persists

    Keep out of reach of children

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

    Directions

    • Cleanse the skin thoroughly before applying medication.
    • Cover the entire affected area with a thin layer 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.
    • For children under 10 years of age, consult your physician.

    Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Amur Cork Tree (Phellodendron Amurense) Bark Extract, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Benzyl Alcohol, Capryloyl Glycine, Chinese Rhubarb (Rheum Palmatum ) Root Extract, Chlorphenesin, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Great Burnet (Sanguisorba Officinalis) Root Extract, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Sodium Phytate, Tromethamine, Water, Xanthan Gum

    Questions or Comments?

    1-855-626-6606

  • Step 3 - Acne Face MoisturizerDrug Facts

    Active Ingredient

    Salicylic acid 2.0%

    Purpose

    Acne Treatment

    Use

    • For the treatment of acne

    Warnings

    For external use only

    When using this product

    • Avoid unnecessary sun exposure and use sunscreen.
    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

    Stop use and ask a doctor

    • If irritation persists

    Keep out of reach of children

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

    Directions

    • Cleanse the skin thoroughly before applying medication.
    • Cover the entire affected area with a thin layer 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.
    • For children under 10 years of age, consult your physician.

    Inactive Ingredients

    Alcohol, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbyl Tetraisopalmitate, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Behenyl Alcohol, Benzyl Alcohol, Capryloyl Glycine, Carbomer, Cetyl Alcohol, Chlorphenesin, Chinese Rhubarb (Rheum Palmatum) Root Extract, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Dicaprylyl Carbonate, Fragrance, Glucose, Glycerin, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Phenethyl Alcohol, Plankton Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Shea Butter (Butyrospermum Parkii), Sodium Hydroxide, Sodium Phytate, Squalane, Stearyl Alcohol, Water, Xanthan Gum.

    Questions or Comments?

    1-855-626-6606

  • SPL UNCLASSIFIED SECTION

    Made in USA
    Manufactured for Kamedis, New Jersey 07601
    1-855-626-6606

    www.kamedis-usa.com

  • Carton Label

    image description

    image description

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    CLEAR ACNE KIT 
    acne kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50718-0034
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0034-11 in 1 CARTON01/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 100 mL
    Part 21 BOTTLE 22 mL
    Part 31 BOTTLE 50 mL
    Part 1 of 3
    CLEAR ACNE FACE CLEANSER 
    acne face cleanser liquid
    Product Information
    Item Code (Source)NDC:50718-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID14.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PURSLANE (UNII: M6S840WXG5)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SQUALANE (UNII: GW89575KF9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    SODIUM COCOYL APPLE AMINO ACIDS (UNII: EB3U1PA61T)  
    METHYL GLUCOSE (UNII: QCF122NF3R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0031-11 in 1 CARTON
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2018
    Part 2 of 3
    CLEAR ACNE SPOT TREATMENT 
    acne spot treatment liquid
    Product Information
    Item Code (Source)NDC:50718-0032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID28.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)  
    PURSLANE (UNII: M6S840WXG5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    PICEA ABIES WOOD (UNII: 72GZ8K8996)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SARCOSINE (UNII: Z711V88R5F)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0032-11 in 1 CARTON
    122 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2018
    Part 3 of 3
    CLEAR ACNE FACE MOISTURIZER 
    acne face moisturizer lotion
    Product Information
    Item Code (Source)NDC:50718-0033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID28.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ALCOHOL (UNII: 3K9958V90M)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PURSLANE (UNII: M6S840WXG5)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PICEA ABIES WOOD (UNII: 72GZ8K8996)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SARCOSINE (UNII: Z711V88R5F)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    SQUALANE (UNII: GW89575KF9)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    NORI (UNII: 477TV3P5UX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0033-11 in 1 CARTON
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2018
    Labeler - Kamedis (080311300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biogenesis Inc.069117328manufacture(50718-0034)