Label: NATUREPLEX PSORIASIS- salicylic acid cream

  • 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 January 12, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Psoriasis and seborrheic dermatitis

  • Uses

    Reduces and helps prevent recurrence of

    • itching
    • irritation
    • redness
    • flaking and scaling due to psoriasis and seborrheic dermatitis
  • Warnings

    For external use only.

    Ask a doctor before use if condition covers a large area of the body

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if condition worsens or does not improve after regular use.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    Apply to affected areas one to four times daily or as directed by a doctor.

  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    alcohol denatured, caprylic/capric triglyceride, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, methylparaben, mineral oil, polysorbate-20, propylene glycol, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA, vitamin A (as retinyl palmitate), vitamin D (as cholecalciferol)

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Natureplex™
    PSORIASIS
    Medicated Moisturizer

    NET WT. 1 Oz. (28g)

    NDC 67234-073-01

    Salicylic
    Acid 2%

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NATUREPLEX PSORIASIS 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-073-011 in 1 CARTON07/24/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/24/2019
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-073)
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