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Refuge HC (CoValence Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 30 g in 1 JAR (66915-531-01) Label Information
CREAM 200000 g in 1 DRUM (66915-531-02) Label Information

Complete Refuge HC Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:66915-531
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE .01 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66915-531-01 30 g in 1 JAR
    2 NDC:66915-531-02 200000 g in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/02/2011
    Labeler - CoValence Inc. (070659375)
    Establishment
    Name Address ID/FEI Business Operations
    CoValence Inc. 070659375 manufacture