Label: ARCTIVA PSORIASIS CREAM- psoriasis cream cream

  • NDC Code(s): 58418-822-45, 58418-822-99
  • 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 February 1, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient
    Salysilic Acid 2%.........

  • PURPOSE

    Purpose.... Psoriasis

  • INDICATIONS & USAGE

    Uses: Temporarily protects and helps relieve minor skin irritation and itching due to psoriasis.

  • 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, Glyceryl Stearate,

    Candelilla/Jojoba/Rice Bran Polyglyceryl- 3

    Esters, Sodium Hydroxide, Sodium stearoyl

    lactylate, Cetearyl Alcohol, Phenoxyethanol,

    Pentylene Glycol, Hydrosurf (Glycolipids),

    Hydroxyethylcellulose, Ethylhexyglycerin,

    Sodium Ascorbyl Phosphate, Vitamin B3

    (Niacinamide), 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 60days of your purchase for a

    full refund.

    Distributed by:

    Arctiva Wellness, LLC

    30600 Aurora Rd.

    Suite 180

    Solon, OH 44139

    Made in U.S.A

    arctivaskin.com

  • PRINCIPAL DISPLAY PANEL

    label

    outer carton

  • INGREDIENTS AND APPEARANCE
    ARCTIVA PSORIASIS CREAM 
    psoriasis cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-822
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.6 g  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    RICE BRAN (UNII: R60QEP13IC)  
    LIPID A 504 (UNII: Q2VF73396U)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    Colorwhite (lotion) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-822-991 in 1 CARTON02/01/2023
    1NDC:58418-822-45130 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 finalM03202/01/2023
    Labeler - Tropical Enterprises International, Inc. (091986179)
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