Other
Drug Facts
Alevex Spray
FDA Label NDC 0280-0049
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc for the product Alevex (NDC 0280-0049). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, purpose, indications & usage, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
(To Deliver)
Camphor 5.5%
Menthol 16%
Purpose
Pain Relieving Spray
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- strains
- sprains
- bruises
Provides penetrating pain relief
Warnings
For external use only
Flammable: do not use near heat, flame, or while smoking.
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 membranes
- use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
- contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F
- do not bandage tightly
- do not use with a heating pad, medicated patch or other types of local heat
- do not apply to wounds or damaged, broken or irritated skin
Stop Use And Ask A Doctor If
- condition worsens or irritation develops
- pain, swelling or blistering develops where product was applied
- redness or severe burning develops where product was applied
- symptoms 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.
Otc - 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 older |
|
| Children under 12 years of age |
|
Other Information
- store between 20°-25°C (68°-77°F)
Inactive Ingredients
boswellia carterii oil, clove oil, dimethylaminoethyl methacrylate copolymer, dimethyl isosorbide, eucalyptus oil, fragrance, isobutane, isopentane, isopulegol, linseed oil, menthoxypropanediol, pepermint oil, propane, propanediol, rosemary oil, SD alcohol 40-B (13% v/v), thymus mastichina flower oil, tocopherol, vanillyl butyl ether, vinyl caprolactam, vinylpyrrolidone
Questions
1-800-395-0689
Package Label Display
ALEVEX™
PAIN RELIEVING
SPRAY
MAX
STRENGTH
MENTHOL
COOLS IN
SECONDS
FOR EXTERNAL
USE ONLY
NET WT 3.2 OZ (91 g)
* Please review the disclaimer below.
