SPL v10
SPL
SPL Set ID 378d1109-6511-1f63-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (35 mg)
Inactive Ingredients
Camphor (natural) Methylparaben Trolamine Fd&c Yellow No. 5 Aloe Vera Leaf Isopropyl Alcohol Ilex Paraguariensis Leaf Alpha-tocopherol Fd&c Blue No. 1 Water Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-11

Description

Active Ingedients Purpose Menthol USP 3.5%................... Topical Analgesic

Purpose

Menthol USP 3.5% Topical Analgesic

Dosage and Administration

Directions: Adults and children 2 years of age and older Apply to painful muscles and joints. Genthly massage thoroughly into affected area. Repeat as necessary but not more than 4 times daily.


Medication Information

Purpose

Menthol USP 3.5% Topical Analgesic

Dosage and Administration

Directions:

Adults and children 2 years of age and older

Apply to painful muscles and joints. Genthly massage thoroughly into affected area.

Repeat as necessary but not more than 4 times daily.

Description

Active Ingedients Purpose Menthol USP 3.5%................... Topical Analgesic

Uses:

USES:

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

Warnings

Warnings:

For external use only.

Directions:

Directions:

Adults and children 2 years of age and older:

Apply to painful muscles and joints. Genthly massage throughly into affected area.

Repeat as necessary but not more than 4 times daily.

Other Information:

Other information: Stiore in a cool dry place with lid closed tightly.

Inactive Ingredients:

Aqueous (Deionized filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *IlexParaguariensis leaf extract, Cinnamomum Camphora (camphor),Tocopheryl Avetate (Vitamin E Acetate), Carbomer, FD&C Blue #1, FD&C Yellow #5, Methylparaben, Triethanolamine.

Principle Display Panel

When Using This Product:

When using this product:

Avoid contact with the eyes or mucous membranes.

Do not apply to wounds or damaged skin.

Do not use with other ointments , creams, sprays or linaments.

Do not apply to irrated skin or excessive irration develops.

Do not bandage.

Wash hands after use with cool water.

Dop not use with heating pad or device.

Otc Active Ingredient Section

Active Ingedients Purpose

Menthol USP 3.5%................... Topical Analgesic

If Pregnant Or Breast Feeding:

If pregnant or breast feeding: Ask a health professional before use.

Keep Out of Reach of Children:

Keep out of reach of children. If accidenthly ingested get medical help or contact a Poison Control Center.

Stop Use and Ask A Doctor If::

Stop use and ask a Dictor if: Condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur.

Ask A Doctor Before Use If You Have:

Ask a doctor before use if you have sensitive skin.


Structured Label Content

Uses: (USES:)

USES:

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

Purpose

Menthol USP 3.5% Topical Analgesic

Warnings

Warnings:

For external use only.

Directions:

Directions:

Adults and children 2 years of age and older:

Apply to painful muscles and joints. Genthly massage throughly into affected area.

Repeat as necessary but not more than 4 times daily.

Other Information: (Other information:)

Other information: Stiore in a cool dry place with lid closed tightly.

Inactive Ingredients:

Aqueous (Deionized filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *IlexParaguariensis leaf extract, Cinnamomum Camphora (camphor),Tocopheryl Avetate (Vitamin E Acetate), Carbomer, FD&C Blue #1, FD&C Yellow #5, Methylparaben, Triethanolamine.

Principle Display Panel

When Using This Product: (When using this product:)

When using this product:

Avoid contact with the eyes or mucous membranes.

Do not apply to wounds or damaged skin.

Do not use with other ointments , creams, sprays or linaments.

Do not apply to irrated skin or excessive irration develops.

Do not bandage.

Wash hands after use with cool water.

Dop not use with heating pad or device.

Dosage and Administration

Directions:

Adults and children 2 years of age and older

Apply to painful muscles and joints. Genthly massage thoroughly into affected area.

Repeat as necessary but not more than 4 times daily.

Otc Active Ingredient Section (OTC-ACTIVE INGREDIENT SECTION)

Active Ingedients Purpose

Menthol USP 3.5%................... Topical Analgesic

If Pregnant Or Breast Feeding: (If pregnant or breast feeding:)

If pregnant or breast feeding: Ask a health professional before use.

Keep Out of Reach of Children: (Keep out of reach of children:)

Keep out of reach of children. If accidenthly ingested get medical help or contact a Poison Control Center.

Stop Use and Ask A Doctor If:: (Stop Use and ask a doctor if::)

Stop use and ask a Dictor if: Condition worsens, or if symptoms persist for more than 7 days or clear up and reoccur.

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

Ask a doctor before use if you have sensitive skin.


Advanced Ingredient Data


Raw Label Data

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