ALEVEX- camphor and menthol lotion

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
Camphor 5.5%
Menthol 16%

Purpose

Pain Relieving Lotion

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

Warnings

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

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
• 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

• 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 healthcare professional before use.

Keep out of reach of children

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

Directions

• 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

store between 20º-25ºC (68º-77ºF)

Inactive ingredients

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?

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

AleveX Carton label 72 grams

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)

INGREDIENTS AND APPEARANCE

ALEVEX 
camphor and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0050
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
LINSEED OIL (UNII: 84XB4DV00W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
ISOPULEGOL (UNII: 3TH92O3BXN)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ROSEMARY OIL (UNII: 8LGU7VM393)
THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TOCOPHEROL (UNII: R0ZB2556P8)
CLOVE OIL (UNII: 578389D6D0)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0050-01	1 in 1 CARTON	04/01/2021
1		72 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

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)