Label: HYDROCORTISONE 1%- hydrocortisone cream

  • NDC Code(s): 69396-081-01
  • 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

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  • DRUG FACTS

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Uses

    temporary relieves external anal itching.

    temporary relief of itching associated with minor skin irritations and rashes

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

  • When Using this Product

    Avoid Contact with eyes

    do not exceed the recommended daily dosage unless directed by a doctor

    do not put into the rectum by using fingers or any mechanical device or applicator

  • Warnings

    for external use only

  • Directions

    ●Adults when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.

    ●gently dry by patting or blotting with a tissue or soft cloth before application of this product.

    ●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

    ●children under 12 years of age: do not use, consult a doctor.

  • Inactive ingredients

    Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate

  • Other information

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

  • Keep out of Reach of Children

    If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)

  • Stop Use and Ask a Doctor if

    bleeding occurs

    condition worsens

    symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

  • Qustions or Comments

    Call 1 800 296-9067

  • Do Not Use

    Do not use for the treatment of Diaper Rash. Consult Doctor.

  • Other Information

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2020 CVS Pharmacy

    CVS.com

    1 800 Shop CVS

    Made in China

    V-36582

    This product is not manufactured or distributed by Pfizer, distributor of Preparation H Anti-itch Cream.

  • Packaging

    CDER 397141 CVS Hydrocortisone

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 1% 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-081
    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 MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-081-011 in 1 BOX06/23/2021
    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 finalpart34806/23/2021
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
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