SPL v27
SPL
SPL Set ID 70eda21e-e566-42f4-9a49-b0d3ad000652
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


Medication Information

Purpose

Menthol USP 3.5%Topical Analgesic

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.

Warning

Warning

For external Use only.

Directions

ADirections:

Adults and children 2 years of age and older:

Apply to painful muscles and joints. Genthly massage thtoughly into affected areas.

Repeat as necessary but not more than 4 times daily.

Other Information

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

Inactive Ingredients

Inactive Ingredients:

Aqueou(Deionized water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *Ilex Paraguariensis Leaf Extract, Cinnamomum Camphora (camphor), Tocopheryl Acetate (Vitamin E Acetate) Carbomer, FDC Blue #1, FDC Yellow#5, Methylparaben, Triethanolamine.

Principle Dislay 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 nopt apply to irrated skin or ifexcessive irration develops.

Do not bandage.

Wash hands after use with cool water.

Do not use with heating pad or device.

Ask Doctor Before Use If You:

Ask a doctor before use if you have sensitive skin.

Otc Active Ingredient Section

Active Ingedients Purpose

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

Stop Use and Ask A Doctor If:

Stop use and Ask doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

If Pregnant Or Breast Feeding:

If pregrant or breast feeding. Ask a health professional before use.

Keep Out of Reach of Children:

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


Structured Label Content

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

Warning

Warning

For external Use only.

Directions

ADirections:

Adults and children 2 years of age and older:

Apply to painful muscles and joints. Genthly massage thtoughly into affected areas.

Repeat as necessary but not more than 4 times daily.

Other Information (Other information)

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

Inactive Ingredients

Inactive Ingredients:

Aqueou(Deionized water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *Ilex Paraguariensis Leaf Extract, Cinnamomum Camphora (camphor), Tocopheryl Acetate (Vitamin E Acetate) Carbomer, FDC Blue #1, FDC Yellow#5, Methylparaben, Triethanolamine.

Principle Dislay 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 nopt apply to irrated skin or ifexcessive irration develops.

Do not bandage.

Wash hands after use with cool water.

Do not use with heating pad or device.

Ask Doctor Before Use If You: (Ask doctor before use if you:)

Ask a doctor before use if you have sensitive skin.

Otc Active Ingredient Section (OTC-ACTIVE INGREDIENT SECTION)

Active Ingedients Purpose

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

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

Stop use and Ask doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

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

If pregrant 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 accidentally ingested, get medical help or contact Poison Control Center.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)