Label: CVS MAXIMUM STRENGTH ANTI-ITCH CREAM- hydrocortisone 1% 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 April 14, 2022

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  • ACTIVE INGREDIENT

    Hydrocortisone 1.0%

  • PURPOSE

    Anti-itch

  • INDICATIONS & USAGE

    Temporarily relieves external feminine itching

  • WARNINGS

    Avoid contact with the eyes

    If you are allergic to any of the ingredients

    Stop use and ask the doctor if :

    • conditions worsen
    • symptoms last ore than 7 days, or clear up and occur again within a few days

    If swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    • Adults and children 12 years and over: Apply to the external vaginal area more than 3 times a day
    • Children under 12 years: Consult a doctor
  • OTHER SAFETY INFORMATION

    Store at 20-25 C (68-77 F)

  • INACTIVE INGREDIENT

    aloe vera, Ascorbic acid, Cetyl alcohol, Citric acid, Glyceryl stearate, Mineral oil, PEG-100 Stearate, PEG-150 Distearate, Petrolatum, Phenoxyethanol, Polycarbophil, Propylene Glycol, Purified Water, Sodium citrate, Stearyl alcohol, Vitamin A palmitate, Vitamin E acetate, Xanthan Gum.

  • PRINCIPAL DISPLAY PANEL

    dl

  • INGREDIENTS AND APPEARANCE
    CVS MAXIMUM STRENGTH ANTI-ITCH CREAM 
    hydrocortisone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-485
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYCARBOPHIL (UNII: W25LM17A4W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-485-08113 g in 1 TUBE; Type 0: Not a Combination Product04/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/2022
    Labeler - CVS Health (062312574)
    Registrant - Medical Products Laboratories, Inc. (008965063)
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