Label: BEARD MEDICATED CREMO- hydrocortisone 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 January 17, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Hydrocortisone 1% Anti-itch

  • PURPOSE

    Uses

    For temporary relief of itching and minor skin irritation associated to eczema, soaps, detergents, and minor scrapes or scratches

  • 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.
  • INDICATIONS & USAGE

    • Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use and consult a doctor.
  • WARNINGS

    Warnings

    • For External use only
    • When using this product avoid contact with eyes
    • If contact occurs, rinse eyes thoroughly with water
  • DOSAGE & ADMINISTRATION

    Directions

    For adults: apply to affected area not more than 3 to 4 times daily.

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Coconut Oil, Cocoa Butter, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Cetearyl Alcohol, Polysorbate 60, Carbomer, Aminomethyl Propanol, Disodium EDTA, Allantoin, Vitamin E Acetate, Aloe Vera Leaf Extract, Organic Tea Tree Leaf Oil, Lavender Oil, Peppermint Oil, Organic Chamomile Blue (German) Flower Oil.

  • PRINCIPAL DISPLAY PANEL

    Cremo Beard Cream Medicated

    Anti-itch formula

    2 oz 56g

    jar wrap

    jar

  • INGREDIENTS AND APPEARANCE
    BEARD MEDICATED CREMO 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71825-107
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71825-107-0156 g in 1 JAR; Type 0: Not a Combination Product01/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/17/2019
    Labeler - Cremo company (078708508)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose, Inc.083819404manufacture(71825-107)
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