QUATRIDERM ANTI-ITCH (HYDROCORTISONE) CREAM [OPMX LLC]

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QUATRIDERM ANTI-ITCH (HYDROCORTISONE) CREAM [OPMX LLC]
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NDC 69729-269-53
Set ID 83e59e10-9878-e5c2-e053-2a91aa0af25e
Category HUMAN OTC DRUG LABEL
Packager OPMX LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredient

    Hydrocortisone 1 %

  • Uses

    for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

    eczema

    seborrheic dermatitis

    psoriasis

    insect bites

    poison ivy, poison oak, and poison sumac

    cosmetics

    jewelry

    detergents

    soaps

    temporarily relieves external anal and genital itching

    other uses of this product should be only under the advice and supervision of a doctor

  • Warnings

    For external use only

    When using this product

    do not get into the eyes

    for external anal itching, do not use more than directed unless told to do so by a doctor

    do not put into the rectum by using fingers or any mechanical device or applicator

    Do not use

    for the treatment of diaper rash. Ask a doctor.

    for external genital itching if you have a vaginal discharge. Ask a doctor.

    for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

    Stop us and ask doctor if

    condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

    Keep out of reach of children

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

  • Directions

    adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

    children under 2 years: ask a doctor

    for external anal itching in adults:

    when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad.

    gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

    for external anal itching in children under 12 years: ask a doctor

  • Other information

    store at 20 °C to 25 °C (68 °F to 77 °F)

  • Inactive ingredient

    aloe barbadensis (aloe vera) leaf juice, cetearyl alcohol, glycerin, methylparaben, mineral oil, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax

  • Purpose

    Anti-Itch

  • PRINCIPAL DISPLAY PANEL

    01b UC_Quatriderm_2oz

    01b UC_Quatriderm_2oz_DF Box

  • INGREDIENTS AND APPEARANCE
    QUATRIDERM ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-269
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-269-531 in 1 CARTON02/10/2019
    156 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 finalpart34802/10/2013
    Labeler - OPMX LLC (029918743)
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