Label: I DEW CARE TEA TREE O STARTERKIT- salicylic acid kit

  • NDC Code(s): 82904-303-02, 82904-304-01, 82904-305-01, 82904-306-01
  • Packager: Memebox Corporation
  • 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 June 16, 2023

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  • Active Ingredient

    Salicylic Acid 1.5%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne

  • Warnings

    For external use only

  • Warnings

    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.

  • Warnings

    Stop use and ask a doctor if skin irritation occurs or gets worse.

  • Warnings

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

  • Directions

    ■ Pump 1~2 times and massage on wet face in circular motions. ■ Rinse thoroughly with clean water.
    ■ Use daily. AM & PM. ■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • Inactive Ingredients

    Water, Dipropylene Glycol, Glycerin, Disodium Cocoamphodiacetate, Methylpropanediol, Lauryl Hydroxysultaine, Sodium Chloride, Sodium Cocoyl Alaninate, Coco-Betaine, Tromethamine, Acrylates Copolymer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Citric Acid, Hexylene Glycol, Laminaria Japonica Extract, Eclipta Prostrata Leaf Extract, 1,2-Hexanediol, Fructooligosaccharides, Butylene Glycol, Beta-Glucan, Hydrogenated Lecithin, Melaleuca Alternifolia (Tea Tree) Extract, Hydrolyzed Hyaluronic Acid, Propanediol, Citrus Unshiu Peel Extract

  • Label

    IDC_Tea Tree-O StarterKit

  • INGREDIENTS AND APPEARANCE
    I DEW CARE TEA TREE O STARTERKIT 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82904-304
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82904-304-011 in 1 KIT; Type 0: Not a Combination Product09/27/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PUMP 50 mL  in 100 
    Part 21 BOTTLE 11 mL  in 100 
    Part 31 POUCH 24 mL  in 100 
    Part 1 of 3
    I DEW CARE CLEAN ZIT AWAY ACNE FOAMING CLEANSER 
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:82904-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)  
    LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)  
    TANGERINE PEEL (UNII: JU3D414057)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82904-303-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00609/27/2022
    Part 2 of 3
    I DEW CARE ROLL WITH TEA TREE ROLL ON FACEOIL 
    tea tree oil oil
    Product Information
    Item Code (Source)NDC:82904-305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    APPLE SEED OIL (UNII: 9ACA4K9013)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82904-305-0111 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/27/2022
    Part 3 of 3
    I DEW CARE HERES THE TEA TREE 
    tee tree oil patch
    Product Information
    Item Code (Source)NDC:82904-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) (MELALEUCA ALTERNIFOLIA LEAF - UNII:G43C57162K) MELALEUCA ALTERNIFOLIA LEAF0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCOA (UNII: D9108TZ9KG)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MONARDA DIDYMA LEAF (UNII: JY15982UBB)  
    APPLE (UNII: B423VGH5S9)  
    WINE GRAPE (UNII: 3GOV20705G)  
    PAPAYA (UNII: KU94FIY6JB)  
    PRUNUS MUME FRUIT (UNII: 639190I8CU)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    MENTHA SUAVEOLENS LEAF (UNII: 1341ZC68MK)  
    MATRICARIA RECUTITA LEAF (UNII: 6I9LN466F0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    BETAINE (UNII: 3SCV180C9W)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TREHALOSE (UNII: B8WCK70T7I)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ARGININE (UNII: 94ZLA3W45F)  
    GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER (300000 CP AT 2%) (UNII: MEA9KH24QG)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82904-306-0124 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00609/27/2022
    Labeler - Memebox Corporation (067317179)
    Registrant - Memebox Corporation (067317179)
    Establishment
    NameAddressID/FEIBusiness Operations
    KOLMAR KOREA CO., LTD.689512611manufacture(82904-304)
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