FDA.reportPublic FDA data

AleveX Lotion UI1614388

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 01:20:02

Label at a glance#

ProductAleveX
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
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 Children under 12 years of age Ask a Doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

AleveX Lotion

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Camphor 5.5%
Menthol 16%

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 - STOP USE 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 and ask a doctor

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 health 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
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 oil, tocopherol, vanillyl butyl ether

Questions or Comments?

OTC - QUESTIONS SECTION


1-800-395-0689

Package label 2.7 oz.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Lotion 2.7 ozLotion 2.7 oz

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130025866591554GTIN-13: 0025866591554
EAN-13: 0025866591554
GTIN-12: 025866591554
UPC-A: 025866591554
GTIN storage (14 digits): 00025866591554		AleveX - 2.7oz Lotion reduced1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0063-01AleveX77 g in 1 TUBELOTION775

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0063-01GM - Gram0280-00631a677620-824e-4cf5-ac3b-684fda94314c12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00630280-0063-01

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

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 LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
ndc (package): 0280-0063-01
ndc (product): 0280-0063
ndc11 (package): 00280006301
spl id: 45262976-7ea4-6a50-e063-6394a90a1c06
spl set id: bafdf06b-25f5-e29e-e053-2a95a90a5e1b

Reported adverse events (FAERS/openFDA)#

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