Label: PETROCORT ANTIPRURITIC LIP 21- hydrocortisone lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Drug Facts

  • Active Ingredient (in percentage)

    Hydrocortisone 0.5%

    Purpose

    For relief of minor skin irritation.

  • USES:

    Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

  • WARNINGS:

    For external use only. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat.

    Keep out of reach of children.

  • DIRECTIONS:

    Apply to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.

  • INACTIVE INGREDIENTS:

    Petrolatum, Syncrowax HGL-C, Syncorwax ERL-C, Padimate-O Mineral Oil, Propylparaben, Fragrance, FD & C Yellow # 5, FD & C Blue # 1.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PETROCORT ANTIPRURITIC LIP 21 
    hydrocortisone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51822-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
    PADIMATE O (UNII: Z11006CMUZ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51822-021-154.25 g in 1 TUBE; Type 0: Not a Combination Product12/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/26/2017
    Labeler - Clinical Formula LLC (084120658)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clinical Formula LLC084120658manufacture(51822-021)
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