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

AleveX Lotion

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 and ask a doctor

• 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

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
• 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 oil, tocopherol, vanillyl butyl ether

Questions or Comments?

1-800-395-0689

Package label 2.7 oz.

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)

INGREDIENTS AND APPEARANCE

ALEVEX 
camphor and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0063
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)
THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)
ALCOHOL (UNII: 3K9958V90M)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CLOVE OIL (UNII: 578389D6D0)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
LINSEED OIL (UNII: 84XB4DV00W)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
WATER (UNII: 059QF0KO0R)
ROSEMARY OIL (UNII: 8LGU7VM393)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPULEGOL (UNII: 3TH92O3BXN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0063-01	77 g in 1 TUBE; 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)