Alevex Lotion Rollerball Ui 1614338

Alevex Lotion Rollerball Ui 1614338
SPL v5
SPL
SPL Set ID bc66bc1b-c0d5-2481-e053-2a95a90a75de
Route
TOPICAL
Published
Effective Date 2021-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 mg) Camphor (synthetic) (5.5 mg)
Inactive Ingredients
Peppermint Oil Linseed Oil Edetate Disodium Alcohol Water Frankincense Oil Isopulegol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Pentylene Glycol Rosemary Oil Thymus Mastichina Flowering Top Oil Vanillyl Butyl Ether Sorbitan Monooleate 3-((l-menthyl)oxy)propane-1,2-diol Eucalyptus Oil Polysorbate 80 Aminomethylpropanol Tocopherol Clove Oil Glycerin

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Pain Relieving Lotion


Medication Information

Purpose

Pain Relieving Lotion

Description

Drug Facts

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

Section 53414-9

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

Section 55106-9

Active ingredients

Camphor 5.5%

Menthol 16%

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
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 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

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)

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
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)

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

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Active ingredients

Camphor 5.5%

Menthol 16%

Purpose

Pain Relieving Lotion

Stop Use (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
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 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)

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? (Questions or comments?)

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

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
Alevex Carton Label 72 Grams (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)

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.


Advanced Ingredient Data


Raw Label Data

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