FDA.reportPublic FDA data

Aleve X Dry Spray UI1614336

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

Dosage and administration

Adults and children 12 years of age and older Shake well before use Apply to affected area not more than 3 to 4 times daily Do not apply to face Use in a well-ventilated area and avoid inhalation 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

(To Deliver)

Camphor 5.5%

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Spray

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: do not use near heat, flame, or while smoking.

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
  • 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 120ºF
  • 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

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.

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
  • Shake well before use
  • Apply to affected area not more than 3 to 4 times daily
  • Do not apply to face
  • Use in a well-ventilated area and avoid inhalation
  • 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

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

OTC - QUESTIONS SECTION

1-800-395-0689

Package label display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVEX™

PAIN RELIEVING

SPRAY

MAX

STRENGTH

MENTHOL

COOLS IN

SECONDS

FOR EXTERNAL

USE ONLY

NET WT 3.2 OZ (91 g)

AleveX Dry Spray labelAleveX Dry Spray label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130025866591561GTIN-13: 0025866591561
EAN-13: 0025866591561
GTIN-12: 025866591561
UPC-A: 025866591561
GTIN storage (14 digits): 00025866591561		C00010064 - AleveX Dry Spray Can. - Final_Page_1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0049-01AleveX91 g in 1 CANSPRAY915

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
0280-00490280-0049-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ISOBUTANEBXR49TP611IACT
PEPPERMINT OILAV092KU4JHIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
ALCOHOL3K9958V90MIACT
PROPANEDIOL5965N8W85TIACT
ROSEMARY OIL8LGU7VM393IACT
PROPANET75W9911L6IACT
MENTHOLL7T10EIP3AACTIB
FRANKINCENSE OIL67ZYA5T02KIACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHIACT
LINSEED OIL84XB4DV00WIACT
TOCOPHEROLR0ZB2556P8IACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
ISOPENTANEZH67814I0OIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
N-VINYLCAPROLACTAMKFC10CY9UPIACT
THYMUS MASTICHINA FLOWERING TOP OIL9NP0832457IACT
ISOPULEGOL3TH92O3BXNIACT
N-VINYLPYRROLIDINONE76H9G81541IACT
CLOVE OIL578389D6D0IACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
EUCALYPTUS OIL2R04ONI662IACT

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 LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
ndc (package): 0280-0049-01
ndc (product): 0280-0049
ndc11 (package): 00280004901
spl id: 45261ca8-875e-7830-e063-6294a90ab33a
spl set id: bafd199a-e198-d5d1-e053-2995a90ad1cb

Reported adverse events (FAERS/openFDA)#

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