NDC 76348-570 Ak47 Cooling Roll-on

Menthol Roll-on

NDC Product Code 76348-570

NDC 76348-570-01

Package Description: 1 APPLICATOR in 1 BOX > 84 g in 1 APPLICATOR (76348-570-03)

NDC Product Information

Ak47 Cooling Roll-on with NDC 76348-570 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Ak47 Cooling Roll-on is menthol roll-on. The product's dosage form is liquid and is administered via topical form.

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 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.

Ak47 Cooling Roll-on 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.


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.

  • TERPINEOL (UNII: R53Q4ZWC99)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CARYOPHYLLENE (UNII: BHW853AU9H)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • WATER (UNII: 059QF0KO0R)
  • GRAPEFRUIT (UNII: O82C39RR8C)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MYRCENE (UNII: 3M39CZS25B)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • .ALPHA.-PINENE, (+)- (UNII: H6CM4TWH1W)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 06-01-2020 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Ak47 Cooling Roll-on Product Label Images

Ak47 Cooling Roll-on 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

Active ingredient: Menthol 1.25%

Otc - Purpose

Purpose Topical Analgesic

Indications & Usage

  • Usesfor temporary relief of minor aches and pains of muscles and joints associated withbruisessprainsarthritisstrains

Warnings

WarningsFor external use only.

Otc - When Using

  • When using this productDo not bandage tightlyavoid contact with eyesdo not apply to wounds or damaged skindo not use with heating pads or other heating devices.

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • DirectionsAdults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain.children under 12 years of age: do not use, consult a doctor.

Inactive Ingredient

Inactive Ingredients:Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).

Otc - Questions

Questions? [email protected]

Statement Of Identity

AK4
7 TM Cooling Roll-OnPain Relief

Recent Major Changes

USES CHANGED TO VARIOUS BULLET POINTS5/2020DOSAGE AND ADMINISTRATION Changes made to
Directions5/2020

Label And Box

AK47 LABEL AND PRODUCT BOX

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