NDC 70994-105 Cold Sore Relief

Stellaria Media, Salvia Officinalis, Calendula Officials, St. Johns Wort, Rosemary Oil, Plantago Major, Commiphora Myrrha, Comfrey Leaf, Salvia Officinalis, Sunflower Oil

NDC Product Code 70994-105

NDC Code: 70994-105

Proprietary Name: Cold Sore Relief 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: Stellaria Media, Salvia Officinalis, Calendula Officials, St. Johns Wort, Rosemary Oil, Plantago Major, Commiphora Myrrha, Comfrey Leaf, Salvia Officinalis, Sunflower 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
    • 70994-105 - Cold Sore Relief

NDC 70994-105-09

Package Description: 1 CAN in 1 BOX > 19.8 g in 1 CAN (70994-105-01)

NDC Product Information

Cold Sore Relief with NDC 70994-105 is a a human over the counter drug product labeled by Sierra Sage Herbs Llc. The generic name of Cold Sore Relief is stellaria media, salvia officinalis, calendula officials, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower 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.

Cold Sore Relief 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.

  • ACHILLEA MILLEFOLIUM FLOWER 1 [hp_X]/19.8g
  • ST. JOHN'S WORT 1 [hp_X]/19.8g
  • STELLARIA MEDIA 1 [hp_X]/19.8g
  • CALENDULA OFFICINALIS FLOWER 1 [hp_X]/19.8g
  • PLANTAGO MAJOR 1 [hp_X]/19.8g
  • COMMIPHORA MYRRHA WHOLE 1 [hp_X]/19.8g
  • SALVIA OFFICINALIS WHOLE 1 [hp_X]/19.8g
  • COMFREY LEAF 1 [hp_X]/19.8g

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.

  • MELISSA OFFICINALIS (UNII: YF70189L0N)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)
  • ROSEMARY OIL (UNII: 8LGU7VM393)

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: 04-02-2019 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.

Cold Sore Relief Product Label Images

Cold Sore Relief 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 ProtectantAstringentExternal Analgesic

Otc Active Ingredients

Organic Calendula Officinalis (Calendula) Flowers 1X (HPUS)

Organic Stellaria Media (Chickweed) 1X (HPUS)

Organic Plantago Major (Plantain) 1X (HPUS)

Organic Symphytum officinale folia (Comfrey) 1X (HPUS)
Organic Achillea Millefofolium (Yarrow) 1X (HPUS)

Commiphora molmol (myrrh) 1X (HPUS)

Organic Salvia Officinalis (Sage) 1X (HPUS)

Organic Hypericum Perforatum (St. Johns Wort) 1X (HPUS)

Indications & Uses

Temporarily protects and helps relieves minor pain associated with

• cold sores

temporarily protects and helps relieve tingling, blistering and itching due to

• inflammation of cold sores

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Warnings Section

Warnings For external use only.
-Don’t use on damaged or broken skin.

-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 And Handling

Store at room temperature.

Dosage & Administration Section

Apply as often as needed to affected area.

Inactive Ingredients

Organic Cera alba (Beeswax), Organic Helianthus annuus (Sunflower) Oil, Organic Larrea tridentata (Chaparral), Lavandula augustifolia (Lavender) Essential Oil, Organic Melissa officinale (Lemon Balm), Organic Olea europaea (Olive) Oil, Rosemarinus officinalis (Rosemary) Essential Oil, Styrax benzoin (Gum Benzoin), Non-GMO (100% Sunflower) Mixed Tocopherols (Vitamin E).

* Please review the disclaimer below.

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