Label: ARCTIVA ECZEMA CREAM- eczema cream cream

  • NDC Code(s): 58418-821-40, 58418-821-44, 58418-821-45, 58418-821-99
  • Packager: Tropical. Enterprises International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 10, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient
    Colloidal oatmeal 1%......

  • PURPOSE

    Purpose... Skin protectant

  • INDICATIONS & USAGE

    Uses: Temporarily protects and helps relieve minor skin irritations, redness, dryness, cracking and itching

    due to eczema and dermatitis.

  • WARNINGS

    Warnings

    For external use only. When using this product: do not get into eyes.

    Stop using and ask a doctor if: condition worsen, symptoms last more

    than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact

    a Poison. Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions Apply twice daily or as needed.
    For best results apply after cleansing.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cetyl Alcohol, Stearyl Alcohol,

    Candelila/Jojoba/Rice Bran Polyglyceryl-3 esters, Glyceryl Stearate,
    Sodium Hydroxide, Sodium stearoyl lactylate,Cetearyl Alcohol, Phenoxyethanol, Pentylene Glycol,

    Hydrosuf (Glycolipids), Glycolic Acid, Vitamin B3 (Niacinamide), Hydroxyethylcellulose, Ethylhexyglycerin,

    Sodium Ascorbyl Phosphate, Vitamin A (Retinyl Palmitate), Tocopherol, Soybean Oil.

  • STORAGE AND HANDLING

    Other Information: Store at room temperature.

  • QUESTIONS

    Questions: 1-833-933-SKIN (7546)

  • SPL UNCLASSIFIED SECTION

    THE ARCTIVA GUARANTEE

    Arctiva relief goes beyond the surface. If for any reason you're

    not completely satisfied contact us within 60 days of your purchase

    for a full refund.

    Distributed by:

    Arctiva Wellness, LLC

    30600 Aurora Rd.

    Suite 180

    Salon, OH 44139

    Made in U.S.A

    arctivaskin.com

  • 130ml

    Eczema_130mL_label

    Eczema_130mL_outercarton

  • 40ml

    40ml label40ml outer carton

  • INGREDIENTS AND APPEARANCE
    ARCTIVA ECZEMA CREAM 
    eczema cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-821
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    RICE BRAN (UNII: R60QEP13IC)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LIPID A 504 (UNII: Q2VF73396U)  
    Product Characteristics
    Colorwhite (lotion) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-821-991 in 1 CARTON02/01/2023
    1NDC:58418-821-45130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:58418-821-441 in 1 CARTON10/02/2023
    2NDC:58418-821-4040 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 DrugM03202/01/2023
    Labeler - Tropical. Enterprises International, Inc. (091986179)
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