Label: REFUGE HC- hydrocortisone cream

  • NDC Code(s): 66915-531-01, 66915-531-02
  • Packager: CoValence 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 18, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient(s):  Hydrocortisone 1%

  • PURPOSE

    Purpose:  For itchy skin.

  • 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.  Children under 12 years of age:  do not use, consult a physician.

  • INDICATIONS & USAGE

    Use:  For temporary relief of itching and discomfort associated with minor skin irritations, inflammation and rashes.

  • WARNINGS

    Warnings:  For external use only.  Avoid contact with eyes.

  • DOSAGE & ADMINISTRATION

    Directions:  Adults and children 12 years of age or older:  Apply to the affected area no more than 3 to 4 times daily.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Hedychium Coronarium (White Giner) Root Extract, Bisabolol (L-alpha), Rosa Canina (Rose Hip) Fruit Oil, Squalane, Tocopherol (D-alpha), Aloe Barbadensis Leaf Juice Powder, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Glycine Soja (Soybean) Oil, Sorbitan Olivate, Xanthan Gum, Phytic Acid, Carbomer, Potassium Sorbate, Sodium Hydroxide, Calcium Gluconate, Gluconolactone, Sodium Benzoate, Caprylyl Glycol, Phenethyl Alcohol, Trisodium Ethylenediamine Disuccinate
  • PRINCIPAL DISPLAY PANEL

    Prinicpal Display PanelLabel

  • INGREDIENTS AND APPEARANCE
    REFUGE HC 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-531
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE.01 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    SQUALANE (UNII: GW89575KF9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTIC ACID (UNII: 7IGF0S7R8I)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66915-531-0130 g in 1 JAR
    2NDC:66915-531-02200000 g in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/02/2011
    Labeler - CoValence Inc. (070659375)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoValence Inc.070659375manufacture
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