Label: POLEN NATURAL AFTER CARE- emollients ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 6, 2021

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  • ACTIVE INGREDIENT

    Aloe socotrina (aloe) 2X

  • Purpose

    Wound healing

  • Uses

    Helps reduce inflammation, promotes healing and regeneration of skin, and enhances the colors in your tattoos.

  • WARNINGS

    For external use only.

    Avoid contact with eyes, do not apply to deep or puncture wounds.

    Stop use and ask a doctor if condition worsens or symptoms do not improve within 7 days.

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    Gently cleanse and dry area. Apply liberally to affected areas as needed.

  • INACTIVE INGREDIENT

    Almond oil, Beeswax, Calendula oil, Cocoa butter, Coconut oil, Lavender oil, Propolis, Shea butter, Vitamin E

  • PRINCIPAL DISPLAY PANEL

    NDC: 81859-001-02

    Front Label_57 gBack label_57 g

  • INGREDIENTS AND APPEARANCE
    POLEN NATURAL AFTER CARE 
    emollients ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81859-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE2 [hp_X]  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81859-001-0257 g in 1 CANISTER; Type 0: Not a Combination Product05/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/03/2021
    Labeler - V5 Concrete Ltd. (204300297)
    Establishment
    NameAddressID/FEIBusiness Operations
    V5 Concrete Ltd.204300297manufacture(81859-001)
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