Label: PERSONAL LUBRICANT (sambucus nigra flower calendula officinalis flower pine needle oil- pinus sylvestris 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 October 6, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    ORG. SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

    ORG. CALENDULA OFFICINALIS (2X) HPUS) (MARIGOLD)

    PINUS SILVESTRIS (2X) HPUS (PINE RESIN)

    BERBERIS VULGARIS (3X) HPUS (BARBERRY)

  • PURPOSE

    PROPERTIES

    SKIN PROTECTANT

    SKIN PROTECTANT

    SKIN PROTECTANT

    FOR VAGINAL DRYNESS

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DRYNESS, MILD CANDIDA, AND MINOR SORES. NOT TO BE USED SOME LATEX CONDOMS.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO AFFECTED AREA AS NEEDED.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, CANADIAN FIR BALSAM

  • 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. (* = CERTIFIED ORGANIC INGREDIENTS)

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • QUESTIONS

    CUSTOMER SERVICE 310-526-6108

  • OTHER SAFETY INFORMATION

    STORE IN A COOL DRY PLACE OR REFRIGERATE

  • PRINCIPAL DISPLAY PANEL

    personal 1 oz

  • INGREDIENTS AND APPEARANCE
    PERSONAL LUBRICANT 
    sambucus nigra flower calendula officinalis flower pine needle oil (pinus sylvestris) salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER2 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER2 [hp_X]  in 100 mL
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) (PINE NEEDLE OIL (PINUS SYLVESTRIS) - UNII:5EXL5H740Y) PINE NEEDLE OIL (PINUS SYLVESTRIS)2 [hp_X]  in 100 mL
    BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3) BERBERIS VULGARIS FRUIT3 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANADA BALSAM (UNII: K304VI98I3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-801-1130 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(52810-801)
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