Label: ACNE/PIMPLE CONTROL- calendula officinalis flowering top and silicon dioxide solution/ drops

  • NDC Code(s): 51393-6112-1, 51393-6112-2, 51393-6112-4
  • Packager: Forces of Nature
  • 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 November 13, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CONTROL DRUG FACTS

  • Active Ingredients

    Calendula Officinalis1 6X - Promotes healthy skin
    Silicea1 6X - Helps heal acne


    1
    USDA Certified Organic
  • Also Contains

    Lavandin Oil1, Tea Tree Oil1, Rose Geranium Oil1, Rosemary Oil1, Palmarosa Oil1

  • Indications

    Clears up acne, blemishes, reduces skin inflammation associated with acne. Reduces the number of acne blemishes and allows skin to heal. Penetrates pores to control acne and keep skin clear of new acne pimples.

  • Directions

    Wash hands and face with warm soapy water. Moisten cotton ball, add 2-3 drops of product, gently rub over all areas of acne. Can also be applied directly from the bottle. Repeat process three times per day.

  • Warnings

    Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin.

    For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center.

    Do not apply to the eyes. If you are pregnant or breast-feeding, ask a health professional before use. Not for use on children under the age of 3.

    Keep all medicines out of the reach of children.

    Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 7 days.

  • SPL UNCLASSIFIED SECTION

    Manufactured & Distributed by
    FORCES OF NATURE®
    21787 8th St East #3A Sonoma, CA 95476 USA

  • PRINCIPAL DISPLAY PANEL - 4 ml Bottle Box

    ORGANIC

    NDC #51393-6112-4

    FORCES OF NATURE®

    CERTIFIED ORGANIC MEDICINE℠

    Acne/Pimple

    ROLLERBALL APPLICATOR

    Topical Acne Medicine

    • Attacks Blemishes on the Spot
    • Suitable for all Skin Types
    • Penetrates Quickly to Fight
      Acne at its Source
    • Calms Acne Flareups
      & Improves Skin Tone
    • Rare Essential Oils
      by Elite Growers
      from Across
      the Planet

    Calendula
    Officinalis

    .14 OZ/4 ml Rollerball

    PRINCIPAL DISPLAY PANEL - 4 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    ACNE/PIMPLE CONTROL 
    calendula officinalis flowering top and silicon dioxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-6112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP6 [hp_X]  in 1000 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide6 [hp_X]  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Lavandin Oil (UNII: 9RES347CKG)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Geranium Oil, Algerian Type (UNII: 5Q1I94P4WG)  
    Rosemary Oil (UNII: 8LGU7VM393)  
    Palmarosa Oil (UNII: 0J3G3O53ST)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-6112-111 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/06/2011
    2NDC:51393-6112-233 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/06/2011
    3NDC:51393-6112-44 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/06/2011
    Labeler - Forces of Nature (050169130)