NDC 27495-020 Overtime-hmp

Pain Relief Stick

NDC Product Code 27495-020

NDC 27495-020-03

Package Description: .085 g in 1 JAR

NDC Product Information

Overtime-hmp with NDC 27495-020 is a a human over the counter drug product labeled by Physicians Science And Nature, Inc.. The generic name of Overtime-hmp is pain relief stick. The product's dosage form is stick and is administered via topical form.

Labeler Name: Physicians Science And Nature, Inc.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.


Overtime-hmp 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.

  • METHYL SALICYLATE 25 g/.85g
  • MENTHOL 15 g/.85g
  • CAPSAICIN .1 g/.85g

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.

  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
  • LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)
  • COCONUT OIL (UNII: Q9L0O73W7L)

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: Physicians Science And Nature, Inc.
Labeler Code: 27495
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: 05-01-2019 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.

Overtime-hmp Product Label Images

Overtime-hmp 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 Ingredients

Methyl Salicylate 25.00%Menthol 15.00%Capsaicin 0.1%

Purpose

Topical Analgesic

Uses:

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains and strains. Does not prevent or cure any disease.

Warnings:

For external use only. Do not use in or on the eyes, mouth, mucous membranes or genitalia. Do not allow treated skin to contact infants, children or pets. Do not tightly bandage. Do not use with a heating pad. Do not use with topical pain-relieving medications. May result in burning sensation of the skin or skin rash. May rarely result in an increase or decrease effects of other medications, lightheadedness, drowsiness, fatigue, mood changes, hypotension (low blood pressure), dry mouth, psychomotor slowing, changes in appetite and weight. Do not drive or operate machinery if drowsy while using this medication. May rarely result in stains to clothing, bedding or furniture.

Keep Out Of Reach Of Children And Pets.

If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

Consult a physician prior to use. Use only as directed. Priot to first use, rub a small amount on the foremarm to check for sensitivity. Gently rub over painful areas no more than 4 times daily. Do not massage into skin vigorously. Wash hands after each use. If placed into the eyes, rinse with cold water and call for medical help.

Do Not Use:

On cuts, infected skin or over raw or blistered skin, on children under 12 years of age or pets, in large amount, if allergic to any of the listed ingredients, including cannabinoids/cannibidiol or aspirin products, if you are pregnant or nursing, taking anticoagulant medications, if suffering with Parkinson's Disease or severe psychiatric disease. If you have any questions regarding the safe use of this medication, please contact your medical provider.

Stop Use And Ask A Physician:

For severe undiagnosed pain. If pain worsens or persists for more than 7 days. If pain clears up and then recurs in a few days. If itching or skin rash occurs. If any other advierse effects occur.

Inactive Ingredients:

Broad-Spectrum Hemp Extract (300 mg Cannabidiol/THC free), Caprylic/Capric Triglyceride, Ozokerite Wax, Cetearyl Alcohol, Glyceral Behenate, Stearyl Alcohol, Dimethyl Sulfoxide, Avena Sativa, Kernel Oil, Tocopherol, Zingiber Officinale Root Extract, d-Limonene, Fragrance.

Other

FORMULATED BY A PHYSICIAN                           RECOMMENDED BY PHYSICIANSManufactured for Physician's Science and Nature, Inc.220 Newport Center Dr., 11-634, Newport Beach, CA 92660For further information or to place an order visit: www.overtimepainrelief.comMade in the USA

Physician's Science And Nature, Inc.

​OVERTIME-HMPPain Relief StickWITH BROAD-SPECTRUM HEMP EXTRACTDOES NOT CONTAIN THC​CONTAINS 300MG CBDHypoallergenic3 ounces (85 GM) - NDC 27495-020-03

* Please review the disclaimer below.

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