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
  • 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 August 17, 2023

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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 finalM01602/01/2023
    Labeler - Tropical. Enterprises International, Inc. (091986179)
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