Label: ROOSIN- hydrocortisone acetate 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 December 15, 2021

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  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Use

     Temporary relieves itching associated with minor irritations and rashes

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

  • WARNINGS

    For external use only

    Do not use

    • In or near eyes
    • For diaper rash, consult a doctor

    When using this product

    • Do not use any other hydrocortisone products unless you have contacted a doctor

    Stop use and ask a doctor if

    Condition worsens or persists for more than 7 days

    Symptoms clear up and occur within a few days

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

  • Directions

    Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily

    Children under 2 years of age: Do not use

  • Inactive ingredients

    Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

  • Other Information

    Store at room temperature

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ROOSIN 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81552-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    OCTADECANOL (MIXTURE OF ISOMERS) (UNII: C6BPY2QY39)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81552-003-010.9 g in 1 TUBE; Type 0: Not a Combination Product04/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/20/2021
    Labeler - ROOSIN MEDICAL CO., LTD (527587815)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROOSIN MEDICAL CO., LTD527587815manufacture(81552-003)
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