Alevex Lotion Ui1614388

Alevex Lotion Ui1614388
SPL v5
SPL
SPL Set ID bafdf06b-25f5-e29e-e053-2a95a90a5e1b
Route
TOPICAL
Published
Effective Date 2021-04-01
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) Thymus Mastichina Flowering Top Oil Alcohol Sorbitan Monooleate Clove Oil Tocopherol Glycerin Peppermint Oil Frankincense Oil Linseed Oil 3-((l-menthyl)oxy)propane-1,2-diol Pentylene Glycol Water Rosemary Oil Vanillyl Butyl Ether Aminomethylpropanol Isopulegol Edetic Acid Eucalyptus Oil Polysorbate 80

Identifiers & Packaging

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

Description

Drug Facts AleveX Lotion


Medication Information

Description

Drug Facts AleveX 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

Section 42229-5

Drug Facts

AleveX Lotion

Section 53414-9

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

Section 55105-1

Pain relieving lotion

Section 55106-9

Active ingredients

Camphor 5.5%

Menthol 16%

Warnings

For external use only

Flammable: Keep away from fire or flame.

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

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

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

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)

Questions Or Comments?



1-800-395-0689

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
Keep Out of Reach of Children

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


Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

AleveX Lotion

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain relieving lotion

Section 55106-9 (55106-9)

Active ingredients

Camphor 5.5%

Menthol 16%

Warnings

For external use only

Flammable: Keep away from fire or flame.

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

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)

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

Package Label 2.7 Oz. (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)

Questions Or Comments? (Questions or Comments?)



1-800-395-0689

When Using This Product (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 (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
Keep Out of Reach of Children (Keep out of reach of children)

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


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Raw Label Data

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