ALEVEX- camphor and menthol spray

AleveX by

Drug Labeling and Warnings

AleveX by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(To Deliver)

Camphor 5.5%

Menthol 16%

Purpose

Pain Relieving Spray

INDICATIONS & USAGE

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: 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

• store between 20º-25ºC (68º-77ºF)

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)

INGREDIENTS AND APPEARANCE

ALEVEX 
camphor and menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ISOBUTANE (UNII: BXR49TP611)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALCOHOL (UNII: 3K9958V90M)
PROPANEDIOL (UNII: 5965N8W85T)
ROSEMARY OIL (UNII: 8LGU7VM393)
PROPANE (UNII: T75W9911L6)
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0049-01	91 g in 1 CAN; Type 0: Not a Combination Product	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2021

Labeler - Bayer HealthCare LLC (112117283)