Label: POST TREATMENT BALM- hydrocortisone cream

  • NDC Code(s): 62742-4077-1, 62742-4077-2
  • Packager: Allure Labs Inc.
  • 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 3, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient: Hydrocortisone 1%

  • PURPOSE

    Purpose: Anti-itch

  • INDICATIONS & USAGE

    Uses:

    • Promotes healing of itchy skin.
    • Keeps skin hydrated.
  • WARNINGS

    Warnings:

    • For external use only.
    • Ask a doctor if bleeding occurs or conditions worsens.
  • DO NOT USE

    Do not use - If rashes appear on skin.

  • WHEN USING

    When using this Product:

    • Avoid contact with the eyes, lips and mouth.
    • Do not use more than directed unless told to do so by a doctor.
  • STOP USE

    Stop use and ask a doctor - If conditions worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:

    • Occlude eyebrows, outer corners of eyes, nose and lips prior to chemical peel.
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Petrolatum, Carthamus Tinctorius (Safflower) Seed Oil, Tocopheryl Acetate, Zinc Oxide , Titanium Dioxide, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid , Glycosaminoglycans, Dimethicone, Triethoxycaprylylsilane, PEG-8 , Tocopherol , Ascorbyl Palmitate , Ascorbic Acid, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Manufactured for DermaQuest®, Inc.

    Hayward, CA 94544

    1272 GK, NL Made in USA

    dermaquestinc.com

    IMGDQIPTB1oz

  • PRINCIPAL DISPLAY PANEL

    Manufactured for

    DermaQuest®, Inc.

    Hayward, CA-94544

    1272 GK, NL Made in USA

    dermaquestinc.com

    IMGDQIPTB2oz

  • INGREDIENTS AND APPEARANCE
    POST TREATMENT BALM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GAG (UNII: U5T7CTT5KM)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ACETATE ION (UNII: 569DQM74SC)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4077-229.6 g in 1 TUBE; Type 0: Not a Combination Product05/12/2015
    2NDC:62742-4077-156.7 g in 1 TUBE; Type 0: Not a Combination Product05/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/12/2015
    Labeler - Allure Labs Inc. (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4077)
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