Label: AFRICAN BLACK FACIAL CLEANSING BAR ANTI-ACNE CLARIFYING- fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap

  • 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 June 15, 2016

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Fucus Vesiculosus Extract (Tinc) - Reduces sebaceous excretions
    Centella Asiatica Extract (Tinc) - Reduces mild skin inflammation
    Melissa Officinalis Extract (Tinc) - Reduces irritation
    Aloe Socotrina Extract(1X) - Anti bacterial

  • INDICATIONS & USAGE

    Uses: Homeopathic facial cleansing bar for acne prone skin

  • WARNINGS

    ■ For external use only

    ■ Avoid contact with eyes

    ■ If pregnant or breastfeeding, ask a health professional before use.

    ■ If symptoms worsen or persist, consult a physician.

    ■ Discontinue use if skin rash develops..

    Keep out of reach of children.

    ■ If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: ■ Wet bar to create a lather and massage into face using circular motions. Rinse thoroughly.

  • SPL UNCLASSIFIED SECTION

    Other information: For use on mild to moderate acne, or as directed by a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients: Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Fragrance (Parfum), Carbon, Colloidal Oatmeal, Avena Sativa (Oat) Kernel Flour, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Gluconate, Butyrospermum Parkii (Shea) Butter*♥, Alcohol, Salix Alba (Willow) Bark Extract.

    *Certified Organic Ingredient. ♥Fair Trade Ingredient

  • QUESTIONS

    Questions? 631-842-8800 or visit NubianHeritage.com

  • PRINCIPAL DISPLAY PANEL

    Box

  • INGREDIENTS AND APPEARANCE
    AFRICAN BLACK FACIAL CLEANSING BAR ANTI-ACNE CLARIFYING 
    fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58666-3412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS1 [hp_X]  in 1 g
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA1 [hp_X]  in 1 g
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS1 [hp_X]  in 1 g
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    OATMEAL (UNII: 8PI54V663Y)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58666-3412-799 g in 1 BOX; Type 0: Not a Combination Product06/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2016
    Labeler - Sundial Group LLC (832783430)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!