Label: POST-TREATMENT REPAIR CREAM- hydrocortisone cream

  • 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 13, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients: Purpose

    Hydrocortisone 1% Anti-itch

  • PURPOSE

    Uses: For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps and detergents, cosmetics, jewelry.

  • 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

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Do not use this or any other hydrocortisone products unless you have consulted a doctor.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children under 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: Do not use, consult a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Allantoin, Aloe Barbadensis Leaf Juice, Beta Glucan, Bisabolol (and)Zingiber Officinale (Ginger) Root Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Coco-Glucoside (and) Coconut Alcohol, Colloidal Silver, Dimethicone, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate (and) PEG-100 Stearate, Myristyl Myristate, Panthenol, Pentylene Glycol (and) 4-t-Butylcyclohexanol Phenoxyethanol (and) Ethylhexylglycerin, Purified Water, Sclerocarya Birrea Seed Oil, Sodium Polyacrylate, Tocopherol Acetate

  • OTHER SAFETY INFORMATION

    Other Information: Store at 20°C (66° – 77°F)

  • PRINCIPAL DISPLAY PANEL

    VI Derm Beauty

    Post-Treatment Repair Cream

    Anti-itch Cream

    Hydrocortisone 1%

    1 FL OZ / 30 mL

    Post repair cream antiitch

  • INGREDIENTS AND APPEARANCE
    POST-TREATMENT REPAIR CREAM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70484-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    GINGER (UNII: C5529G5JPQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SILVER (UNII: 3M4G523W1G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70484-105-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/13/2020
    Labeler - Vi Medical Products Inc. (063910521)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC021072509manufacture(70484-105)
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