Label: BABY DIAPER RASH- calendula officinalis flower, sambucus nigra flower 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

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

    ORG. SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

  • 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_BabyDiaperRash

  • INGREDIENTS AND APPEARANCE
    BABY DIAPER RASH 
    calendula officinalis flower, sambucus nigra flower salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-216
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-216-1130 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)
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