NDC 69678-121 Extra Strength Eez-away

Menthol

NDC Product Code 69678-121

NDC Product Information

Extra Strength Eez-away with NDC 69678-121 is a a human over the counter drug product labeled by Eezaway Relief Inc. The generic name of Extra Strength Eez-away is menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Eezaway Relief Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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 Eez-away Active Ingredient(s)

Additional informationCallout TooltipWhat 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, UNSPECIFIED FORM 2.5 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • EMU OIL (UNII: 344821WD61)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • POLYOXYL-10 OLEYL ETHER (UNII: JD797EF70J)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM THIOSULFATE (UNII: HX1032V43M)
  • IODINE (UNII: 9679TC07X4)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eezaway Relief Inc
Labeler Code: 69678
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-13-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Eez-away Product Label Images

Extra Strength Eez-away 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 Ingredient:

Menthol 2.50%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises ■ cramps

Warnings

For external use only When using this product ■ use only as directed ■ do not bandage tightly or use with heating pad ■ avoid contact with eyes and mucousmembranes ■ do not apply to wounds or damaged, broken or irritated skin ■ a transient burning sensation or redness may occur uponapplication but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do notexpose the area treated with product to heat or direct sunlightStop 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 daysFlammable ■ keep away from fire or flameIf pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years: ■ apply generously to affected area ■ massage into painful area until thoroughly absorbed into skin■ repeat as necessary, but no more than 3 to 4 times daily■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATERchildren 12 years or younger: ask a doctor

Inactive Ingredients

Emu Oil, Fragrance, Full Spectrum Hemp Extract, Glucam P-20, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate Crystal USP, Tincture of Iodine USP

* Please review the disclaimer below.

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