Label: ANTI-ITCH WITH ALOE- hydrocortisone 1% cream

  • NDC Code(s): 63868-688-01
  • Packager: Chain Drug Marketing Association 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 May 23, 2023

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

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • INDICATIONS & USAGE

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

    • insect bites
    • eczema
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external feminine genital and anal itching
    • Other uses of this product should be only under the advice and supervision of a doctor.
  • Warnings

    For External Use Only

    Do not use for the treatment of diaper rash, consult a doctor.

    For external genital itching if you have a vaginal discharge, consult a doctor.

  • Stop use and ask a doctor

    • Conditions worsen
    • Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
  • Keep out of the reach of children

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

  • Other information

    • Store at controlled room temperature 20º-25ºC (68º-77ºF)
  • Inactive Ingredients

    Aloe Vera (Aloe Barbadensis) leaf juice, Cetostearyl alcohol, Edatate Disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, White Petrolatum, Propylene glycol, Purified Water, Sorbitan Monostearate, Polysorbate 60

  • When using this product

    • Avoid contact with the eyes
    • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
    • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In the case of bleeding, stop use, consult a doctor.
    • do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Directions

    Adults and children 2 years and older

    • apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age

    • do not use, consult doctor

    For external and anal itching

    • adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.

    • Children under 12 years of age with external anal ithcing consult a doctor.
  • Distributed By

    Distributed By CDMA Inc.

    43157 W 9 Mile Rd.

    Novi, MI. 48375

    www.qualitychoice.com

    Questions: 800-935-2362

    Product PRC

  • Packaging

    qc anti itch cream aloe 1oz

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH WITH ALOE 
    hydrocortisone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-688
    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
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-688-011 in 1 BOX08/13/2020
    128.3 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 finalpart34808/13/2020
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)