Label: HARRIS TEETER MAXIMUM STRENGTH ANTI-ITCH- hydrocortisone ointment

  • 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 April 17, 2017

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  • ACTIVE INGREDIENT

    Active ingredients                                          Purpose

    Hydrocortisone 1%.........................................Anti-itch

  • PURPOSE

    Uses

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

    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

    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

    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.

  • INDICATIONS & USAGE

    Directions

    • for itching of skin irritation,
    • 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
    • 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 soft cloth before applying
    • apply to affected area not more 3 to 4 times daily
    • chldren under 12 years of age: ask a doctor

  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20°-25°C (68°-77°F)
    • lot no. & exp. date: see box or crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetyl alcohol, methylparaben, petrolatum, propylparaben, sorbitan monostearate, stearly alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Harris Teeter, LLC

    Matthews, NC 28105

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HARRIS TEETER MAXIMUM STRENGTH ANTI-ITCH 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72036-406
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72036-406-281 in 1 CARTON04/17/2017
    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 finalpart34804/17/2017
    Labeler - Harris Teeter (047279351)
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