NDC 58666-3414 African Black Facial Cleansing Bar Anti-acne Clarifying

Fucus Vesiculosus, Centella Asiatica, Melissa Officinalis, Aloe

NDC Product Code 58666-3414

NDC Code: 58666-3414

Proprietary Name: African Black Facial Cleansing Bar Anti-acne Clarifying What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Fucus Vesiculosus, Centella Asiatica, Melissa Officinalis, Aloe What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 58666 - Sundial Group Llc
    • 58666-3414 - African Black Facial Cleansing Bar Anti-acne Clarifying

NDC 58666-3414-7

Package Description: 99 g in 1 BOX

NDC Product Information

African Black Facial Cleansing Bar Anti-acne Clarifying with NDC 58666-3414 is a a human over the counter drug product labeled by Sundial Group Llc. The generic name of African Black Facial Cleansing Bar Anti-acne Clarifying is fucus vesiculosus, centella asiatica, melissa officinalis, aloe. The product's dosage form is soap and is administered via topical form.

Labeler Name: Sundial Group Llc

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

African Black Facial Cleansing Bar Anti-acne Clarifying Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FUCUS VESICULOSUS 1 [hp_X]/g
  • CENTELLA ASIATICA 1 [hp_X]/g
  • MELISSA OFFICINALIS 1 [hp_X]/g
  • ALOE 1 [hp_X]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM COCOATE (UNII: R1TQH25F4I)
  • COCOA SHELL (UNII: DAF1887C02)
  • SALIX ALBA LEAF (UNII: M7S08QZ9JA)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sundial Group Llc
Labeler Code: 58666
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

African Black Facial Cleansing Bar Anti-acne Clarifying Product Label Images

African Black Facial Cleansing Bar Anti-acne Clarifying Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

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

Otc - Purpose

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Ask Doctor

■ If symptoms worsen or persist, consult a physician.

Otc - Stop Use

■ Discontinue use if skin rash develops..

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

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

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

Otc - Questions

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

* Please review the disclaimer below.

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