NDC 72593-154 Allg Essentials Warm-up Accelerator

Camphor (synthetic)

NDC Product Code 72593-154

NDC Product Information

Allg Essentials Warm-up Accelerator with NDC 72593-154 is a a human over the counter drug product labeled by Global Products Group, Llc. The generic name of Allg Essentials Warm-up Accelerator is camphor (synthetic). The product's dosage form is cream and is administered via topical form.

Labeler Name: Global Products Group, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.


Allg Essentials Warm-up Accelerator 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.

  • CAMPHOR (SYNTHETIC) 5 mg/100g

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.

  • METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • CALCITRIOL (UNII: FXC9231JVH)
  • CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ESCIN (UNII: RUU8G67GQM)
  • GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • TROLAMINE SALICYLATE (UNII: H8O4040BHD)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)

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: Global Products Group, Llc
Labeler Code: 72593
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: 03-15-2019 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.

Allg Essentials Warm-up Accelerator Product Label Images

Allg Essentials Warm-up Accelerator 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

Other

Drug Facts

  • Store at room temperature with the cap closedNotice: because this product contains natural nutrients, color may vary

Active Ingredients

Camphor 5%

Purpose

Counterirritant

Uses

  • Minor arthritis painsimple backachemuscle sprainsbruisesmuscle strainscramps

Warnings

For external use only

Do Not Use If

  • Skin is irritated or damagedexcessive irritation develops12 years of age or under

When Using This Product

  • Avoid contact with the eyes and mucous membranesdo not apply to wounds, damaged, broken or irritated skindo not bandage tightly or use a heating paddo not swallow. If swallowed, contact a physician or contact a poison control center immediately.

Stop Use And Ask Doctor If

  • Condition worsessymptoms persist for more than 7 days or clear up and occur again within a few daysredness develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Cleanse, rinse and dry skin prior to applicationapply generously to painful muscles and joints, gently massaging until the ALLG ® Warm-up Accelerator Cream disappears.repeat as necessary but no more than four times a dayfor optimum benefit, use daily for at least two weeks.

Inactive Ingredients

Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aescin (Horse Chestnut Extract), Aloe Vera, Arnica Montana Extract, C12-15 Alkyl Benzoate, Calcium Fructoborate, Chondroitin Sulfate, Diazolidinyl Urea, Dimethicone, Disodium EDTA, dl Panthenol, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Hemp Oil, Hydroxypropyl methylcellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Shea Butter, Tocopheryl Acetate, Trolamine Salicylate

* Please review the disclaimer below.

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