Label: PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT- salicylic acid kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2024

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  • Drug Facts

  • Active ingredient(s)

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne

  • Warnings

    For external use only

    When using this product skin irritation and dryness is likely to occur if you use another topical acne product at the same time. If irritation occurs, only one medication should be used.

    Do not use if you are allergic to the dressing or to any of the components.

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

  • Directions

    • Cleanse thoroughly before applying medication.
    • Apply the sticker on the affected areas. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dyrness or peeling occurs, reduce application to once a day or every other day.
    • Sensitivity test for a new user: Apply product to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
  • Inactive ingredients

    Acrylates Copolymer, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, Water (Aqua/Eau), Alcohol Denat., Melaleuca Alternifolia (Tea Tree) Leaf Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Volcanic Ash, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Sodium Metabisulfite, Butylene Glycol, Phytosphingosine, Phenoxyethanol, Polysorbate 80, PVP.

  • Questions or comments?

    Call toll free 1-888-243-0646 24/7, 365

    Report serious adverse reactions to: 83 Morse St. Suite 8A Norwood, MA 02062

  • Company Information

    DIST. BY RARE BEAUTY BRANDS, INC.

    NORWOOD, MA 02062

    DESIGNED IN THE USA

    MADE IN KOREA

  • Product Packaging

    breakout box rev

  • INGREDIENTS AND APPEARANCE
    PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72204-002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72204-002-011 in 1 BOX; Type 0: Not a Combination Product06/03/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PATCH 0.5 g
    Part 20 PACKET 1 
    Part 30 PACKET 1 
    Part 1 of 3
    BLEMISH SHRINKING SALICYLIC ACID DOTS 
    salicylic acid patch
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALCOHOL (UNII: 3K9958V90M)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    124 in 1 PACKET
    10.5 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/03/2019
    Part 2 of 3
    DETOXIFYING CHARCOAL NOSE STRIPS 
    other preparations (i.e., those preparations that do not fit another category) strip
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRHAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    INGRCOPOVIDONE K25-31 (UNII: D9C330MD8B)  
    INGRBENTONITE (UNII: A3N5ZCN45C)  
    INGRACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    INGRPOVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    INGRKAOLIN (UNII: 24H4NWX5CO)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRMENTHOL (UNII: L7T10EIP3A)  
    INGRSODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/03/2019
    Part 3 of 3
    ABSORBING HYDROCOLLOID DOTS 
    other preparations (i.e., those preparations that do not fit another category) patch
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    INGRPOLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    124 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/03/2019
    Labeler - Iontera, Inc (004818058)
    Registrant - Iontera, Inc (004818058)
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