NDC 0280-0063 Alevex

Camphor And Menthol

NDC Product Code 0280-0063

NDC 0280-0063-01

Package Description: 77 g in 1 TUBE

NDC Product Information

Alevex with NDC 0280-0063 is a a human over the counter drug product labeled by Bayer Healthcare Llc. The generic name of Alevex is camphor and menthol. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Bayer Healthcare Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Alevex 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.

  • CAMPHOR (SYNTHETIC) 5.5 mg/g
  • MENTHOL 16 mg/g

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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • CLOVE OIL (UNII: 578389D6D0)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • LINSEED OIL (UNII: 84XB4DV00W)
  • 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • WATER (UNII: 059QF0KO0R)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ISOPULEGOL (UNII: 3TH92O3BXN)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • ALCOHOL (UNII: 3K9958V90M)

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: Bayer Healthcare Llc
Labeler Code: 0280
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: 04-01-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Alevex 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 FactsAleveX Lotion

Otc - Active Ingredient

Active ingredients
Camphor 5.5%

Menthol 16%

Otc - Purpose

Pain relieving lotion

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated witharthritissimple backachestrainssprainsbruisesProvides penetrating pain relief

Warnings

For external use onlyFlammable: Keep away from fire or flame.

Do Not Use

  • If you have ever had an allergic reaction to this product or any of its ingredients

When Using This Product

  • Avoid contact with the eyes and mucous membranesdo not bandage tightlydo not use with a heating pad, medicated patch or other types of local heatdo not apply to wounds or damaged, broken or irritated skin

Stop Use And Ask A Doctor

  • Condition worsens or irritation developspain, swelling or blistering develops where product was appliedredness or severe burning develops where product was appliedsymptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

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

Keep Out Of Reach Of Children

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

Directions

  • Adults and children 12 years of age and olderApply to affected area not more than 3 to 4 times dailyWash hands with soap and water after useChildren under 12 years of ageAsk a Doctor

Other Information

Store between 20º-25ºC (68º-77ºF)

Inactive Ingredients

Aminomethyl propanol, boswellia carterii oil, carbomer interpolymer, clove oil, edetate disodium, eucalyptus oil, fragrance, glycerin, isopulegol, linseed oil, menthoxypropanediol, pentylene glycol, peppermint oil, polysorbate 80, purified water, rosemary oil, SD alcohol 40-B (20.9 % v/v), sorbitan monooleate, thymus mastichina flower oil, tocopherol, vanillyl butyl ether

Package Label 2.7 Oz.

NEW!DIFFERENT INGREDIENTSMENTHOL + CAMPHORAleveX™Pain RelievingLotionMAXSTRENGTHMENTHOLLONG LASTING COOLINGFOR EXTERNALUSE ONLYNET WT 2.7 OZ (77g)

* Please review the disclaimer below.