Label: HYDROCORTISONE- cool relief gel with aloe gel

  • NDC Code(s): 13709-318-01
  • Packager: NeilMed Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 21, 2023

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

  • Drug Facts

    Active Ingredients

    Hydrocortisone 1%

  • Drug Facts

    Purpose : Anti-itch

  • Drug Facts

    Uses:

    ■ temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak and sumac ■insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should oonly be under the advise and supervison of a doctor

  • Warnings: For external use only

    Warnings: For external use only

  • Do not use

    Do not use

    ■ in the genital area if you have a vaginal discharge. Consult a doctor.

    ■ for the treatment of diaper rash. Consult a doctor.

  • When using this product

    When using this product

    ■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

  • Stop use and ask a doctor if

    Stop use and ask a doctor if ■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. ■ rectal bleeding occurs

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

  • Directions

    Directions ■ for itching of skin irritation, inflammation, and rashes: ■ 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 ■ If pregnant or breast-feeding: ask a health professional before use. ■ for external anal and genital itching, adults: ■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor

  • Inactive ingredients:

    Aloe extract, ascorbic acid, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, chamomile extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, PEG-40 stearate, petrolatum, purified water, sd 40 alcohol, vitamin A, vitamin D and vitamin E

  • SAFE HANDLING WARNING

    TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

  • PRINCIPAL DISPLAY PANEL

    Cool relief gel

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    cool relief gel with aloe gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-318
    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
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A (UNII: 81G40H8B0T)  
    ALCOHOL (UNII: 3K9958V90M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE (UNII: V5VD430YW9)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-318-011 in 1 CARTON08/21/2023
    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 not finalpart34808/21/2023
    Labeler - NeilMed Pharmaceuticals Inc (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc799295915manufacture(13709-318)