79740-008 信息更新

79740-008 信息更新
SPL v2
SPL
SPL Set ID d600e4c6-6547-5944-e053-2995a90a8698
Route
TOPICAL
Published
Effective Date 2022-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Edetate Disodium Ethylhexylglycerin 1,2-propanediol, 1-benzoate Aloe Vera Leaf Isopropyl Myristate Methyl Salicylate Eucalyptus Oil Water Clove Caryophyllene Glyceryl Monostearate Phenoxyethanol Caprylyl Glycol Camphor Leaf Oil Carbomer Homopolymer, Unspecified Type Aminomethylpropanol Capsaicin Azulene Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-20

Description

Menthol 2%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 2%

Use

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

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

Section 50567-7

When using this product

avoid contact with the eyes or mucous membranes.

do not apply to wounds or damaged skin.

do not apply to the irritated skin .

do not bandage.

wash hands after use with cool water .

do not use with heating pad or device.

Warnings

Warnings For external use only.

Directions

Adults and children 12 years of age and older: Apply to affected area not more than3 to 4 times daily.

Children under 12 years of age : Consult physician.

Do Not Use

do not use with heating pad or device.

Other Information

/

Active Ingredient(s)

Menthol 2%

Inactive Ingredients

Purified Water, Propylene Glycol USP, Organic Aloe Vera Juice, Isopropyl Myristate, Ceteareth 20, Methyl Salicylate, Eucalyptus Oil, Wintergreen Oil, Camphor Oil, Clove Bud, Beta-Caryophyllene(Clove), Glyceryl Stearate, Phenoxyethanol, Caprylyl Glycol, Ethyloxiglycerin, Disodium EDTA, Capsaicin, Organic Azulene, Carbomer, Aminomethyl Propanol

Package Label Principal Display Panel


Structured Label Content

Use

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes or mucous membranes.

do not apply to wounds or damaged skin.

do not apply to the irritated skin .

do not bandage.

wash hands after use with cool water .

do not use with heating pad or device.

Purpose

Topical Analgesic

Warnings

Warnings For external use only.

Directions

Adults and children 12 years of age and older: Apply to affected area not more than3 to 4 times daily.

Children under 12 years of age : Consult physician.

Do Not Use (Do not use)

do not use with heating pad or device.

Other Information (Other information)

/

Active Ingredient(s)

Menthol 2%

Inactive Ingredients (Inactive ingredients)

Purified Water, Propylene Glycol USP, Organic Aloe Vera Juice, Isopropyl Myristate, Ceteareth 20, Methyl Salicylate, Eucalyptus Oil, Wintergreen Oil, Camphor Oil, Clove Bud, Beta-Caryophyllene(Clove), Glyceryl Stearate, Phenoxyethanol, Caprylyl Glycol, Ethyloxiglycerin, Disodium EDTA, Capsaicin, Organic Azulene, Carbomer, Aminomethyl Propanol

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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