BABY ECZEMA RELIEF (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER) SALVE [PUREMEDY]

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BABY ECZEMA RELIEF (CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER) SALVE [PUREMEDY]
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NDC 52810-217-11
Set ID 1b81ef0c-2ab6-4f1b-a062-06a776491bb2
Category HUMAN OTC DRUG LABEL
Packager PUREMEDY
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    ORG. CALENDULA OFFICINALIS (1X) HPUS) (MARIGOLD)

    ORG. SAMBUCUS NIGRA (1X) HPUS (ELDER BARK AND FLOWER)

  • PURPOSE

    PURPOSE

    SOOTHES RASH, IRRITATION

    REMEDY FOR SWELLING

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DIAPER RASH AND MINOR SKIN IRRITATIONS. SOOTHES SKINS AND PROTECTS AGAINST MOISTURE TP PROMOTE HEALING.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO CLEAN SKIN AFTER EACH DIAPER CHANGE OR AS DIRECTED BY YOUR PHYSICIAN. MAY ALSO BE USED AS A DAILY SKIN PROTECTANT.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS, ORG. COCOA BUTTER, ORG. MILK THISTLE, ORG. ST. JOHN'S WORT, ORG. ALOE VERA GEL, ORG. NON-GMO VITAMIN E

  • WARNINGS

    WARNINGS: DO NOT USE IF ALLERGIC TO OR SENSITIVE TO ANY INGREDIENT IN THIS SALVE. TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. IF CONDITION PERSISTS OR WORSENS AFTER 3 DAYS SEE A DOCTOR. AVOID DIRECT CONTACT WITH EYES. USE ONLY AS DIRECTED. KEEP ALL DRUGS OUT OF USE OF CHILDREN. SAFE TO USE FOR ALL AGES.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

  • STORAGE AND HANDLING

    STORE IN A COOL DRY PLACE OR REFRIGERATE.

  • QUESTIONS

    CUSTOMER SERVICE 818-851-9014

  • PRINCIPAL DISPLAY PANEL

    1oz_BabyEczema

  • INGREDIENTS AND APPEARANCE
    BABY ECZEMA RELIEF 
    calendula officinalis flower, sambucus nigra flower salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANADA BALSAM (UNII: K304VI98I3)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SILYBUM MARIANUM SEED (UNII: U946SH95EE)  
    ST. JOHN'S WORT (UNII: UFH8805FKA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-217-1130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2012
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    COASTAL CONTRACT PACKAGING, INC.137341611manufacture(52810-217)
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