Label: BABY ACNE- calendula officinalis flower, sambucus nigra flower, thuja occidentalis 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 (ELDER BARK AND FLOWER)

    ORG. THUJA OCCIDENTALIS (1X) HPUS (ARBOR VITAE)

  • PURPOSE

    PURPOSE

    SKIN HEALING AGENT

    REMEDY FOR SWELLING

    REMEDY FOR ACNE

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH BABY ACNE.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TOPICALLY AS NEEDED OR AS DIRECTED BY YOUR PHYSICIAN.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, ORG. COCOA BUTTER, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS

  • 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

    BABY ACNE

  • INGREDIENTS AND APPEARANCE
    BABY ACNE 
    calendula officinalis flower, sambucus nigra flower, thuja occidentalis salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-214
    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
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CANADA BALSAM (UNII: K304VI98I3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-214-1130 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(52810-214)
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