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Drug Facts
AleveX Lotion
Alevex Lotion
FDA Label NDC 0280-0063
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 0280-0063). 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, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, 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
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 with
- arthritis
- simple backache
- strains
- sprains
- bruises
Provides penetrating pain relief
Warnings
For external use only
Flammable: 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 membranes
- 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
- 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
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
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
Questions Or Comments?
1-800-395-0689
Package Label 2.7 Oz.
NEW!
DIFFERENT INGREDIENTS
MENTHOL + CAMPHOR
AleveX™
Pain Relieving
Lotion
MAX
STRENGTH
MENTHOL
LONG LASTING
COOLING
FOR EXTERNAL
USE ONLY
NET WT 2.7 OZ (77g)
* Please review the disclaimer below.
