Label: AFRICAN BLACK ACNE-PRONE FACE AND BODY BAR- fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap
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Contains inactivated NDC Code(s)
NDC Code(s): 58666-3413-7 - Packager: Sundial Group LLC
- 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 December 7, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
AFRICAN BLACK ACNE-PRONE FACE AND BODY BAR
fucus vesiculosus, centella asiatica, melissa officinalis, aloe soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58666-3413 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:58666-3413-7 99 g in 1 BOX; Type 0: Not a Combination Product 11/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/30/2017 Labeler - Sundial Group LLC (832783430)