Label: COOLING ITCH RELIEF spray

  • NDC Code(s): 13709-310-01
  • Packager: NeilMed Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

If you are a consumer or patient please visit this version.

  • OTC Active Ingredient Section

    Hydrocortisone 1% Anti itch

    Principal Display Panel Anti Itch Spray.jpg

  • USES

    Temporarily relieves itching associated with minorskin irritation and rashes due to:• eczema • poison ivy, oak and sumac • cosmetics• psoriasis • soaps and detergents • jewelry• insect bites • seborrheic dermatitis

  • WARNINGS

    For external use only

  • DO NOT USE

    • in or near the eyes • for external genital • vaginal or anal itching • for diaper rash: ask a doctor

  • WHEN USING THIS PRODUCT

    • Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure• Do not store at temperature above 120F

  • STOP USE AND ASK A DOCTOR IF

    • condition worsens or does not improve withing 7 days• symptomspersist more than 7 days or clear up and occur again within a few days

  • KEEP OUT OF REACH OF THE CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • INACTIVE INGREDIENT

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

  • Dosage and Administration

    See Attached Image File Principal Display Panel Anti Itch Spray

  • Indication & Usage

    For the temporary relief of itching associated with minor
    skin irritation and rashes due to: • eczema • poison ivy, oak and
    sumac • cosmetics • jewelry • soaps and detergents • insect
    bites. Other uses of this product should be only under the advice
    and supervision of a doctor.

    Warnings
    For external use only.
    Flammable: Keep away from fire or flame
    Avoid contact with the eyes. If condition worsens, or if symptoms
    persist for more than 7 days or clear up and occur again within a
    few days, stop use of this product and do not begin use of any
    other hydrocortisone product unless you have consulted a doctor.
    Do not use for the treatment of diaper rash. Consult a doctor.
    Do not puncture or incinerate. Contents under pressure. Do not
    store at temperatures above 120˚F

  • OTC - Keep Out of Reach of Children

    Keep out of reach of the children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Anti-Itch Spray

    Anti-Itch Spray

  • INGREDIENTS AND APPEARANCE
    COOLING ITCH RELIEF 
    cooling itch relief spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-310-0185 g in 1 CAN; Type 0: Not a Combination Product11/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/08/2018
    Labeler - NeilMed Pharmaceuticals, Inc (799295915)