Label: BIOELEMENTS IMMEDIATE COMFORT- hydrocortisone acetate lotion

  • Category: HUMAN PRESCRIPTION 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 24, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Hydrocortisone Acetate 1% Anti-itch lotion

    Uses

    For the temporary relief of itching associated with minor skin irritations and rashes due to exzema, detergents, cosmetics, jewelry, dermatitis, psoriasis.

    Other uses of this product should be only under the advice and supervision of a doctor.

    Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

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

    Warnings

    For external use only

    When using this product avoid contact with the eyes.

    Directions

    Apply to affected area no more than 3 to 4 times daily.

    Inactive ingredients

    Butylene Glycol, C12-15 Alkyl Benzoate, Carbomer, Glyceryl Stearate, Helianthuus annus (sunflower) Seed Oil, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Ploysorbate 80, Sodium Hydroxide, Sorbitol, Tocopheryl Acetate, Water (Aqua, Eau)

  • PRINCIPAL DISPLAY PANEL

    image of bottle art

    Bioelements PROFESSIONAL-USE-ONLY

    Immediate comfort

    1% Hydrocortisone Acetate Lotion

    88 ml/ 3 Fl Oz.

  • INGREDIENTS AND APPEARANCE
    BIOELEMENTS  IMMEDIATE COMFORT
    hydrocortisone acetate lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49825-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.088 mL  in 88 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49825-126-0188 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/23/2012
    Labeler - Bioelements, Inc. (174813923)
    Registrant - Bioelements, Inc. (174813923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Labs016754201manufacture(49825-126)
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