84214-009

84214-009
SPL v1
SPL
SPL Set ID 3e08cc87-2385-0838-e063-6394a90abf9b
Route
topical
Published
Effective Date 2025-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (4 g)
Inactive Ingredients
ethyloxirane propylene glycol aminomethyl propanol water gaultheria procumbens (wintergreen) leaf oil eucalyptus oil camphor oil edetate disodium phenoxyethanol caprylyl glycol beta-caryophyllene glyceryl stearate aloe vera leaf ceteareth-20 azulene carbomer isopropyl myristate clove oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-05

Purpose

Topical Anesthetic

Description

Menthol 4%


Medication Information

Warnings

For external use only

Purpose

Topical Anesthetic

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

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

Description

Menthol 4%

Principal Display Panel

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

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

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 4%

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only

Purpose

Topical Anesthetic

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

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)

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

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

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 4%

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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