Label: BABY SKIN- pine needle oil, sambucus nigra flower, calendula officinalis flower, echinacea angustifolia 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

    PINUS SILVESTRIS (2X) HPUS (PINE RESIN)

    ORG. SAMBUCUS NIGRA (3X) HPUS (ELDERBERRY)

    ORG. CALENDULA OFFICINALIS (6X) HPUS (MARIGOLD)

    ORG. ECHINACEA ANGUSTIFOLIA (6X) HPUS (ECHINACEA)

  • PURPOSE

    PROPERTIES

    SKIN PROTECTANT

    ANTI-INFLAMMATORY

    PROMOTES SKIN HEALING

    REMEDY FOR WOUNDS

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH SKIN IRRITATIONS, ECZEMA, RASH, DRY SKIN, CUTS, BURNS, OPEN WOUNDS, AND MUCH MORE.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO AFFECTED AREA 3-4 TIMES PER DAY AS NEEDED. COVER WITH A BANDAID IF NECESSARY.

  • INACTIVE INGREDIENT

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

  • 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

    baby 1 oz

  • INGREDIENTS AND APPEARANCE
    BABY SKIN 
    pine needle oil, sambucus nigra flower, calendula officinalis flower, echinacea angustifolia salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA6 [hp_X]  in 100 mL
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER3 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER3 [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
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-201-1130 mL in 1 JAR; Type 0: Not a Combination Product10/18/2012
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2012
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUREMEDY003552251manufacture(52810-201)
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