Label: CBDMEDIC ITCH AND RASH- allantoin, lidocaine hcl ointment

  • Category: HUMAN OTC DRUG LABEL

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 March 6, 2019

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  • Active Ingredients and Purpose

    Allantoin 0.5% (Skin Protectant),
    Lidocaine HCl 0.5% (External Analgesic)

  • Uses

    For temporary relief and protection from itching associated with minor skin irritations and rashes.

  • Warnings

    For external use only. Do not use on wounds or damaged skin. Avoid contact with eyes or mucous membranes. If symptoms persist for more than 7 days, discontinue use and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast feeding, contact a physician prior to use.

  • Directions:

    Adults and children 12 years of age and older: Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged
    skin. Store at room temperature. Children under 12 years of age: ask a doctor.

  • INDICATIONS & USAGE

  • Inactive ingredients

    Beeswax (organic), cotton seed oil, hemp extract (THC-free), jojoba seed oil, palmarosa oil, peppermint oil, silver oxide, sorbic acid, stearic
    acid (vegetable derived), tea tree oil, zinc oxide

  • PRINCIPAL DISPLAY PANEL

    CBDMEDIC Itch Rash

  • INGREDIENTS AND APPEARANCE
    CBDMEDIC ITCH AND RASH 
    allantoin, lidocaine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    COTTONSEED OIL (UNII: H3E878020N)  
    HEMP (UNII: TD1MUT01Q7)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-731-401 in 1 CARTON03/06/2019
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/06/2019
    Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC018950611manufacture(24909-731) , label(24909-731)
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