NDC 70983-023 Extra Strength

Menthol And Methyl Salicylate

NDC Product Code 70983-023

NDC 70983-023-01

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 45 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Extra Strength with NDC 70983-023 is a a human over the counter drug product labeled by Saje Natural Business Inc.. The generic name of Extra Strength is menthol and methyl salicylate. The product's dosage form is oil and is administered via topical form.

Labeler Name: Saje Natural Business Inc.

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.

Extra Strength 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.

  • MENTHOL 94.41 mg/mL
  • METHYL SALICYLATE 123.74 mg/mL

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.

  • CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
  • KUNZEA AMBIGUA WHOLE (UNII: R09L2486DI)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ORIGANUM MAJORANA (UNII: R40XM3HU5X)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • BETULA LENTA BARK (UNII: J689T0DVJQ)
  • ELETTARIA CARDAMOMUM WHOLE (UNII: KH2S76267N)

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: Saje Natural Business Inc.
Labeler Code: 70983
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-13-2019 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.

Extra Strength 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

Otc - Active Ingredient

Menthol 10.5%, Methyl Salicylate 13.4%

Otc - Purpose

External analgesic (Counterirritant)

Indications & Usage

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruise • sprains

Warnings

For external use only

Flammable

Keep away from fire and flame

Otc - Do Not Use

Do not use on wounds or damaged skinDo not bandage tightlyDo not use if you are allergic to plants of the asteraceae/compositae/daisy family

Otc - When Using

Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil

Otc - Stop Use

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Centre right way.

Dosage & Administration

Adults: apply to affected area no more than 3 to 4 times daily.

Storage And Handling

Store at room temperature.

Inactive Ingredient

Anthemis nobilis flower oil, elettaria cardamomum seed oil, kunzea ambigua branch/leaf/twig oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, trifolium pratense (clover) flower extract, vitis vinifera (grape) seed oil

Other Safety Information

Important: Read all product information before using. Keep this package for full information.

Do not use if security seal around bottle is broken or missing.

Questions? Call 1-877-275-7253

distributed by: saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness

Description

Extra Strength

Pain Relieving Oil Blend

1.5 fl oz (45 ml)

* Please review the disclaimer below.