NDC 70994-506 Belly Balm

Rosehip Seed Oil

NDC Product Code 70994-506

NDC Code: 70994-506

Proprietary Name: Belly Balm 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: Rosehip Seed Oil 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

  • 70994 - Sierra Sage Herbs Llc
    • 70994-506 - Belly Balm

NDC 70994-506-08

Package Description: 113.4 g in 1 JAR

NDC 70994-506-10

Package Description: 1 CAN in 1 BOX > 51.7 g in 1 CAN (70994-506-02)

NDC Product Information

Belly Balm with NDC 70994-506 is a a human over the counter drug product labeled by Sierra Sage Herbs Llc. The generic name of Belly Balm is rosehip seed oil. The product's dosage form is salve and is administered via topical form.

Labeler Name: Sierra Sage Herbs Llc

Dosage Form: Salve - A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).

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.

Belly Balm 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.

  • ROSA MOSCHATA OIL 3.3 g/100g
  • CALENDULA OFFICINALIS FLOWER 1 [hp_X]/100g

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: Sierra Sage Herbs Llc
Labeler Code: 70994
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: 07-09-2019 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.

Belly Balm Product Label Images

Belly Balm 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

Purpose Section

Skin Protectant

Active Ingredients

Organic Rosa Canina (Rosehip Seed) Oil 3.3 %Organic Cocoa Butter 3.57%

Indications & Usage

-temporarily relieves symptoms related to • itchy skin • dry skin-helps to moisturize • pregnant tummy • stretch marks • dry skin-temporarily helps to reduce the appearance • stretch marks

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Warnings Section

Warnings For external use only.• Don’t use on deep wounds.

• When using this product keep out of eyes. Rinse with water to remove.
• Stop using and ask a doctor if rash or irritation occurs.

Storage

Store at room temperature.

Dosage & Administration Section

Apply as often as needed to affected area.

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Simmondsia Chinensis (Jojoba) Seed Oil, Organic Vitellaria Paradoxa (Shea) Butter, Tocopherol, Lavandula Angustifolia (Lavender) Oil.

* Please review the disclaimer below.

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