Aleve X Dry Spray Ui1614336

Aleve X Dry Spray Ui1614336
SPL v5
SPL
SPL Set ID bafd199a-e198-d5d1-e053-2995a90ad1cb
Route
TOPICAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (5.5 mg) Menthol (16 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Isobutane Peppermint Oil Alcohol Propanediol Rosemary Oil Propane Frankincense Oil Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer Linseed Oil Tocopherol 3-((l-menthyl)oxy)propane-1,2-diol Isopentane Vanillyl Butyl Ether N-vinylcaprolactam Thymus Mastichina Flowering Top Oil Isopulegol N-vinylpyrrolidinone Clove Oil Dimethyl Isosorbide Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-01
Description

Drug Facts

Purpose

Pain Relieving Spray

Medication Information

Indications and 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

Purpose

Pain Relieving Spray

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Section 55106-9

Active ingredients

(To Deliver)

Camphor 5.5%

Menthol 16%

Warnings

For external use only

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

Questions

1-800-395-0689

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

Do Not Use
  • if you have ever had an allergic reaction to this product or any of its ingredients
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

Package Label Display

ALEVEX™

PAIN RELIEVING

SPRAY

MAX

STRENGTH

MENTHOL

COOLS IN

SECONDS

FOR EXTERNAL

USE ONLY

NET WT 3.2 OZ (91 g)

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

Structured Label Content

Indications and Usage (34067-9)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Active ingredients

(To Deliver)

Camphor 5.5%

Menthol 16%

Purpose

Pain Relieving Spray

Warnings

For external use only

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

Questions

1-800-395-0689

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

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • store between 20º-25ºC (68º-77ºF)
Inactive Ingredients (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

Package Label Display (Package label display)

ALEVEX™

PAIN RELIEVING

SPRAY

MAX

STRENGTH

MENTHOL

COOLS IN

SECONDS

FOR EXTERNAL

USE ONLY

NET WT 3.2 OZ (91 g)

When Using This Product (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 (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:28.978815 · Updated: 2026-03-14T23:11:00.469021