NDC 70994-305 Face Wash

Calendula

NDC Product Code 70994-305

NDC Product Information

Face Wash with NDC 70994-305 is a a human over the counter drug product labeled by Sierra Sage Herbs Llc. The generic name of Face Wash is calendula. The product's dosage form is oil and is administered via topical form.

Labeler Name: Sierra Sage Herbs Llc

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Face Wash 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.

  • CALENDULA OFFICINALIS FLOWER 1 [hp_X]/133mL

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.

  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)

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.

Face Wash Product Label Images

Face Wash 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 Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

Indications & Usage

■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked skin■ helps prevent and protect from the drying effects of wind and cold weather■ temporarily protects and helps relieve minor skin irritation and itching due to■ rashes ■ dry skin ■ rashes caused by soaps, detergents, cosmetics, or jewelry

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Warnings Section

WarningsFor external use only.■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns

■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than
7 days or clear up and occur again within a few days

■ When using this product keep out of eyes. Rinse with water to remove.

Storage

Store at room temperature.

Dosage & Administration Section

Apply small amount and rinse with warm water.

Inactive Ingredients

Organic Olea Europae (Olive) Fruit Oil, Organic Hlianthus Annuus (Sunflower) Seed Oil, Organic Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil.

* Please review the disclaimer below.

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