ALEVEX- camphor and menthol spray 
Bayer HealthCare LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aleve X Dry Spray UI1614336

Drug Facts

Active ingredients

(To Deliver)

Camphor 5.5%

Menthol 16%

Purpose

Pain Relieving Spray

For the temporary relief of minor aches and pains of muscles and joints associated with:

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 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

  • 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

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

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

Directions

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

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)

AleveX Dry Spray label

ALEVEX 
camphor and menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ISOBUTANE (UNII: BXR49TP611)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
LINSEED OIL (UNII: 84XB4DV00W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
PROPANEDIOL (UNII: 5965N8W85T)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ISOPENTANE (UNII: ZH67814I0O)  
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
N-VINYLCAPROLACTAM (UNII: KFC10CY9UP)  
THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)  
ISOPULEGOL (UNII: 3TH92O3BXN)  
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
CLOVE OIL (UNII: 578389D6D0)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PROPANE (UNII: T75W9911L6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0049-0191 g in 1 CAN; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2021
Labeler - Bayer HealthCare LLC (112117283)

Revised: 2/2021
Document Id: bafd199a-e199-d5d1-e053-2995a90ad1cb
Set id: bafd199a-e198-d5d1-e053-2995a90ad1cb
Version: 1
Effective Time: 20210210
 
Bayer HealthCare LLC