Label: ITCH RELIEF- hydrocortisone 1% cream

  • NDC Code(s): 69396-057-01
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 January 17, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Keep out of Reach of Children

    If Swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to

    • Eczema
    • Insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • sunburn
    • temporarily relieves external anal and genital itching.

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

  • Warnings

    For External Use Only

    Do not use

    • In the genital area if you have a vaginal discharge.
  • When using this Product

    • Avoid contact with the eyes.
    • Do not use more than directed unless told to do so by a doctor.
    • Do not put directly into rectum by using fingers or any mechanical device or applicator.
  • Stop Using this product and ask a doctor if

    • Conditions worsen
    • Symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
    • Rectal bleeding occurs.
  • Directions

    For itching or skin irritations, inflammation, and rashes.

    Adults and children 2 years and older

    • Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age

    • ask a doctor.

    For External and Anal Itching

    • Adults: When practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • Children under 12 years of age: ask a doctor
  • Other Information

    Store at controlled room temperature 20°-25°C (68°-77°F)

  • Inactive Ingredients

    Aloe Barbadensis leaf juice, cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, Glycerin, Glyceryl stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2- Phenoxyethyl alcohol, Polysorbate 80, Propylene glycol, purified water, Stearic acid, Trisodium citrate dihydrate, Vitamin E.

  • Questions

    Call 1-800- SHOP CVS

  • Other Information

    This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10®

    Distributed By:

    CVS Pharmacy, Inc.

    One CVS Drive,

    Woonsocket, RI. 02895

    Product of China V-36756

  • Packaging

    CVS 340113 Hydrocortisone cream

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    hydrocortisone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-057
    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
    3-METHYLPENTADECANE (UNII: X64R3JC095)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-057-011 in 1 BOX09/17/2020
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/15/2020
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)