Label: ACNE FREE- echinacea angustifolia, calendula officinalis flower, sambucus nigra flower, mahonia aquifolium fruiting top salve

  • 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 January 11, 2024

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    ECHINACEA ANGUSTIFOLIA (2X) HPUS (ECHINACEA)

    SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

    ORGANIC CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

    PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

  • PURPOSE

    PROPERTIES

    ACNE TREATMENT

    SKIN PROTECTANT

    SKIN PROTECTANT

    SKIN PROTECTANT

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH ACNE

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY LIBERALLY TO AFFECTED AREA 2-4 TIMES PER DAY OR AS NEEDED. MAY BE USED AS A FACE CREAM OR SPOT TREATMENT.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: ORGANIC EXTRA VIRGIN OLIVE OIL, ORGANIC SAFFLOWER OIL, ORGANIC BEESWAX, CANADIAN FIR BALSAM, ORGANIC TEA TREE OIL.

  • WARNINGS

    WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • OTHER SAFETY INFORMATION

    STORE IN A COOL DRY PLACE OR REFRIGERATE

  • PRINCIPAL DISPLAY PANEL

    acne 1 oz label

  • INGREDIENTS AND APPEARANCE
    ACNE FREE 
    echinacea angustifolia, calendula officinalis flower, sambucus nigra flower, mahonia aquifolium fruiting top salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 mL
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER1 [hp_X]  in 100 mL
    MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN) (MAHONIA AQUIFOLIUM FRUITING TOP - UNII:P119855ERN) MAHONIA AQUIFOLIUM FRUITING TOP1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    CANADA BALSAM (UNII: K304VI98I3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-102-1260 mL in 1 JAR; Type 0: Not a Combination Product10/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2012
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUREMEDY003552251manufacture(52810-102)
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