Label: 999 ITCH RELIEVING- hydrocortisone ointment

  • 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 February 11, 2015

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  • ACTIVE INGREDIENTS

    Hydrocortisone 1.0%

  • Purpose

    Anti-Itch

  • Use

    For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: cosmetics, insect bites, psoriasis, eczema, seborrheic dermatitis.

  • Warnings

    For external use only. Avoid contact with the eyes. If swallowed, get medical help or contact a Poison Control Center right away.

  • Stop use and seek medical advice if

    Condition worsens. Symptoms persist for more than 7 days. Symptoms clear up and occur again within a few days. Excessive irritation of the skin develops.

  • Directions

    Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction.

  • PREGNANCY OR BREAST FEEDING

    Pregnant and children under 2 years of age. Do not use, consult a doctor.

  • Keep out of reach of children.

  • Other Information

    Keep in a tightly closed container. Store at 8 to 30 ℃ (46-86℉) in a dry place away from sunlight.

    You may report serious side effects to: 1452 W. Holt Ave, Pomona, CA 91768

  • Inactive Ingredients

    Glyceryl Monostearate

    Glyceryl Distearate

    Glycerin

    Stearic Acid

    Mineral Oil

    Petrolatum

    Paraffin

    Ceresin

    Beta Carotene

    Ethylparaben

    Sodium Lauryl Sulfate

  • Drug Facts

    carton

  • SPL UNCLASSIFIED SECTION

    Manufactured By Guangdong CR. Shunfeng Pharmaceutical Co.; Ltd.

    Jinjuzu, Dalinag Street, Shunde District, Foshan, Guangdong, China 528300

    Distributed by Master Herbs Inc.

    1452 W. Holt Ave, Pomona, CA 91768

    (866)487-8373

  • INGREDIENTS AND APPEARANCE
    999 ITCH RELIEVING 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69436-930
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CERESIN (UNII: Q1LS2UJO3A)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69436-930-201 in 1 BOX
    120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/20/1989
    Labeler - Guangdong CR. Shunfeng Pharmaceutical Co Ltd (654033877)
    Registrant - Guangdong CR. Shunfeng Pharmaceutical Co Ltd (654033877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong CR. Shunfeng Pharmaceutical Co Ltd654033877manufacture(69436-930)
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