FDA.reportPublic FDA data

AleveX Lotion Rollerball UI 1614338

Manufacturer
Bayer HealthCare LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:03

Label at a glance#

ProductAleveX
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure10 sections

Indications and 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

Dosage and administration

Adults and children 12 years of age and older Apply to affected area not more than 3 to 4 times daily Wash hands with soap and water after use if product comes in contact with hands Children under 12 years of age Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Camphor 5.5%
Menthol 16%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Lotion

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only
Flammable: Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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 SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older
  • Apply to affected area not more than 3 to 4 times daily
  • Wash hands with soap and water after use if product comes in contact with hands
Children under 12 years of age
  • Ask a doctor

Other information

OTHER SAFETY INFORMATION

store between 20º-25ºC (68º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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, tocopherol, vanillyl butyl ether

Questions or comments?

OTC - QUESTIONS SECTION

1-800-395-0689 (Mon - Fri 9AM - 5PM EST)

AleveX Carton label 72 grams

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!
DIFFERENT INGREDIENTS
MENTHOL + CAMPHOR
ALEVEX™
PAIN RELIEVING
LOTION
MAX STRENGTH
MENTHOL
MASSAGING
STAINLESS
STEEL
ROLL-ON
FOR EXTERNAL
USE ONLY
NET WT 2.5 OZ. (72 g)

AleveX label 72 gramsAleveX label 72 grams

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0050-01AleveX1 in 1 CARTONLOTION15
0280-0050-01AleveX72 g in 1 BOTTLE, WITH APPLICATORLOTION725

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00500280-0050-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
LINSEED OIL84XB4DV00WIACT
EDETATE DISODIUM7FLD91C86KIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
FRANKINCENSE OIL67ZYA5T02KIACT
ISOPULEGOL3TH92O3BXNIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PENTYLENE GLYCOL50C1307PZGIACT
ROSEMARY OIL8LGU7VM393IACT
THYMUS MASTICHINA FLOWERING TOP OIL9NP0832457IACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
SORBITAN MONOOLEATE06XEA2VD56IACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
EUCALYPTUS OIL2R04ONI662IACT
POLYSORBATE 806OZP39ZG8HIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
TOCOPHEROLR0ZB2556P8IACT
CLOVE OIL578389D6D0IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
ndc (package): 0280-0050-01
ndc (product): 0280-0050
ndc11 (package): 00280005001
spl id: 45261b62-142c-8c69-e063-6294a90a011f
spl set id: bc66bc1b-c0d5-2481-e053-2a95a90a75de

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.