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

AFRICAN BLACK FACIAL CLEANSING BAR ANTI-ACNE CLARIFYING by

Drug Labeling and Warnings

AFRICAN BLACK FACIAL CLEANSING BAR ANTI-ACNE CLARIFYING by is a Homeopathic medication manufactured, distributed, or labeled by Sundial Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58666-3412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	1 [hp_X]  in 1 g
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	1 [hp_X]  in 1 g
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	1 [hp_X]  in 1 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58666-3412-7	99 g in 1 BOX; Type 0: Not a Combination Product	06/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/15/2016

Labeler - Sundial Group LLC (832783430)