Label: POISON OAK AND IVY- hydrocortisone, phenol gel

  • NDC Code(s): 57479-102-01
  • Packager: DeMartini Spring Hill Pharmacy, 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 August 24, 2023

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  • ACTIVE INGREDIENT

    HYDROCORTISONE (1%)

    PHENOL (0.538%)

  • PURPOSE

    PURPOSE

    EXTERNAL ANALGESIC

    ASTRINGENT

  • INDICATIONS & USAGE

    USES: POISON OAK, POISON SUMAC, POISON IVY, MOSQUITO BITES, OTHER ALLERGIC RASHES.

  • WARNINGS

    WARNINGS: FOR EXTERNAL USE ONLY. DO NOT USE ON EEP OR PUNCTURE WOUNDS, ANIMAL BITES, OR SERIOUS BURNS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP ORCONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE: APPLY DIRECTLY TO THE RASH AREA 3 TO 5 TIMES DAILY OR AS NEEDED FOR THE RELIEF OF ITCHING, REDNESS OR WEEPING.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: SD Alcohol 40-B, Aqua, Witch Hazel Distillate, Alcohol (Ethanol-Natural Grain USP), Acrylates/C10-30, Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, *CO Aloe Vera Leaf Powder, Citrus Limon (Lemon) Peel Oil, Benzyl Alcohol, Blue 1 *CO certified organic

  • WHEN USING

    When using this product
    • Avoid getting in eyes or mucus membranes. If contact occurs rinse thoroughly with water.
    • Discontinue use if allergic to any of the components.

  • STOP USE

    Stop use and ask a doctor if
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • PRINCIPAL DISPLAY PANEL

    Picture1

  • INGREDIENTS AND APPEARANCE
    POISON OAK AND IVY 
    hydrocortisone, phenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57479-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.3 g  in 103 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.54 g  in 103 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LEMON JUICE (UNII: AGN709ANTJ)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57479-102-01103 mL in 1 TUBE; Type 0: Not a Combination Product08/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/24/2023
    Labeler - DeMartini Spring Hill Pharmacy, Inc. (038273603)
    Registrant - DeMartini Spring Hill Pharmacy, Inc. (038273603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(57479-102)
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