Label: NEILMED ANTI-ITCH- anti-itch spray spray

  • NDC Code(s): 13709-239-01
  • Packager: NeilMed Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 11, 2024

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  • Directions:

    Shake well – adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily - children under 2
    years of age: ask a doctor – to apply to face, spray into palm of hand and gently apply

  • Warnings:

    For external use only.
    Flammable: Do not use while smoking or near heat or flame
    Do not use: In or near the eyes; for diaper rash ask a doctor. In case of an accidental exposure rinse with water or saline immediately, remove contact lenses and seek medical help for any persistent symptoms. Use only as directed. Do not puncture or incinerate. Contents under pressure. Avoid long term storage above 104°F. Do not store at temperatures above 120°F
    Ask a doctor before use if you are using any other hydrocortisone or corticosteroid product.
    Stop use and ask doctor if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.
    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Inactive Ingredients:

    Citric Acid, Disodium EDTA, Glycerin,Poloxamer 407, Polysorbate 20, SD Alcohol 40-B,USP grade purified Water.

  • Uses:

    Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to:

    • Eczema ,
    • Poison ivy, oak and sumac
    • Cosmetics
    • Psoriasis
    • Soaps and detergents
    • Jewelry
    • Insect bites
    • Seborrheic dermatitis
  • Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

  • Drug Facts: Purpose


    Anti-itch

  • Drug Facts:


    Active Ingredient
    Hydrocortisone 1.0%

  • NeilMed Anti Itch Spray

    NeilMed Anti-Itch Spray

  • INGREDIENTS AND APPEARANCE
    NEILMED ANTI-ITCH 
    anti-itch spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-239-0190 g in 1 CAN; Type 0: Not a Combination Product11/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/11/2020
    Labeler - NeilMed Pharmaceuticals Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals, Inc.799295915manufacture(13709-239)