84214-010

84214-010
SPL v1
SPL
SPL Set ID 3e090b98-1db7-4174-e063-6394a90aa539
Route
TOPICAL
Published
Effective Date 2025-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Water Isopropyl Myristate Propylene Glycol Aloe Vera Leaf Phenoxyethanol Edetate Disodium Camphor Oil Caprylyl Glycol Glyceryl Stearate Caryophyllene Eucalyptus Oil Ceteareth-20 Gaultheria Procumbens (wintergreen) Leaf Oil Ethyloxirane Azulene Carbomer Aminomethyl Propanol Clove Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-05

Description

Menthol 5%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Menthol 5%

Use

Temporary relief from minor aches and pains of muscles and joints associated with arthritis simple backache strains and sprains

Stop Use

if condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur again within a few days

Warnings

For external use only

Questions

Call 1(888)778-2986

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·do not use with heating pad or device

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

Active Ingredient

Menthol 5%

Inactive Ingredients

Aminomethyl Propanol, Beta-Caryophyllene(Clove),Carbomer,Caprylyl Glycol,Ceteareth 20 ,

Clove Bud,Disodium EDTA ,Ethyloxiglycerin,Eucalyptus Oil,Glyceryl Stearate,Isopropyl Myristate,

Organic Aloe Vera Juice,Organic Azulene,Propylene Glycol USP,Purified Water,Phenoxyethanol,

Wintergreen Oil

Principal Display Panel

Keep Out of Reach of Children

If accidentally ingested get medical help or contact a Poison Control Center immediately.


Structured Label Content

Use

Temporary relief from minor aches and pains of muscles and joints associated with arthritis simple backache strains and sprains

Purpose

Topical Anesthetic

Stop Use

if condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur again within a few days

Warnings

For external use only

Questions

Call 1(888)778-2986

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use (Do not use)

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·do not use with heating pad or device

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

Active Ingredient

Menthol 5%

Inactive Ingredients (Inactive ingredients)

Aminomethyl Propanol, Beta-Caryophyllene(Clove),Carbomer,Caprylyl Glycol,Ceteareth 20 ,

Clove Bud,Disodium EDTA ,Ethyloxiglycerin,Eucalyptus Oil,Glyceryl Stearate,Isopropyl Myristate,

Organic Aloe Vera Juice,Organic Azulene,Propylene Glycol USP,Purified Water,Phenoxyethanol,

Wintergreen Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If accidentally ingested get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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