NDC 81441-006 Vivalacara Dermalere Advanced Skin Cream

Coconut, German Chamomile, Pot-marigold, Helianthus Annuus, D-panthenol, Plantago Major, Urtica Dioica, Cotinus Coggygria

NDC Product Code 81441-006

NDC CODE: 81441-006

Proprietary Name: Vivalacara Dermalere Advanced Skin Cream 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: Coconut, German Chamomile, Pot-marigold, Helianthus Annuus, D-panthenol, Plantago Major, Urtica Dioica, Cotinus Coggygria 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

NDC 81441-006-01

Package Description: 50 mL in 1 TUBE

NDC 81441-006-02

Package Description: 40 mL in 1 TUBE

NDC Product Information

Vivalacara Dermalere Advanced Skin Cream with NDC 81441-006 is a a human over the counter drug product labeled by Bodywell Natural Skin Care Inc. The generic name of Vivalacara Dermalere Advanced Skin Cream is coconut, german chamomile, pot-marigold, helianthus annuus, d-panthenol, plantago major, urtica dioica, cotinus coggygria. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bodywell Natural Skin Care Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Vivalacara Dermalere Advanced Skin Cream 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.

  • COCONUT OIL 6 g/100mL
  • CHAMOMILE 1 g/100mL
  • CALENDULA OFFICINALIS FLOWER 1 g/100mL
  • SUNFLOWER OIL 2 g/100mL
  • DEXPANTHENOL .1 g/100mL
  • URTICA DIOICA LEAF .02 g/100mL
  • PLANTAGO MAJOR LEAF .02 g/100mL
  • COTINUS COGGYGRIA LEAF .02 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALCOHOL (UNII: 3K9958V90M)
  • OLEYL ERUCATE (UNII: 753W099NQ6)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ARGININE (UNII: 94ZLA3W45F)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: Bodywell Natural Skin Care Inc
Labeler Code: 81441
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: 03-24-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Vivalacara Dermalere Advanced Skin Cream Product Label Images

Vivalacara Dermalere Advanced Skin Cream 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

Active Ingredients

Cocos nucifera, German chamomile, Pot-marigold, Helianthus Annuus, D-Panthenol, Plantago major, Urtica dioica, Cotinus coggygria

Purpose

Fast Healing of Wounds & Damaged Skin


Quick Relief of Skin Inflammation & Irritation


Badge - made with calendula and chamomile


Lubricates, protects, and soothes dry, cracked, and chafed skin.


Moisturizes and improves the look of recent scars.

Uses

This product contains Calendula. Calendula officinalis is traditionally used in Herbal Medicine to aid in wound healing and help relieve skin inflammations and irritations. This product contains German Chamomile. Matricaria chamomilla is used in Herbal Medicine to help relieve minor inflammation/or irritation of the skin.

Warnings

For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult a health care professional if symptoms worsen or last for more than 7 days. Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Stop use if hypersensitivity/allergy or irritation occurs. Do not use this product if you are pregnant or breastfeeding.

Keep Out Of Reach Of Children.

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

Directions.

Adults: Apply to affected area as needed.

Other Information.

Do not use on deep or puncture wounds, animal bites or serious burns.

Inactive Ingredients.

Purified water (Water), Stearic acid (Palm Oil), Alcohol (Corn Sugar), Oleyl erucate (Rapeseed Oil), Stearyl alcohol (Palm Oil), Glyceryl monostearate (Palm Oil), Euphorbia Cerifera (Candelilla) Wax (Candelilla Plant), Caprylic/capric triglyceride (Coconut Oil)


Hydroxypropyl starch phosphate (Corn Starch) ,L-Arginine (Glycine Max Plant) ,Hydrogenated castor oil (Castor Oil Plant), Dehydroacetic Acid (Organic Compound), Xanthan Gum (Glucose),Aloe Barbadensis Leaf Juice (Aloe Barbadensis Leaf).

* Please review the disclaimer below.