SPL v7
SPL
SPL Set ID 375bfe83-c895-3ea7-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 Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Water

Identifiers & Packaging

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

Description

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


Medication Information

Description

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

Uses

Uses:

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

Section 51945-4

Section 55105-1

Menthol USP 3.5% Topical Analgesic

Warning

WARNING:

For external use only.

Directions

Directions

Adults and children 2 years of age and older:

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

Repeat as necessary but not more than 4 times daily.

Directions:

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.

Other Infirmation:

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

Inactive Ingredients

Inactive Ingredients:

Aqueous (Deionozed filtered 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, FDCYellow #5, Methylparaben, Triethanolamine.

When Using This Product:

When Using this product:

Avoid contact with the eyes or muscous membranes

Do not apply to wounds or damaged skin

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

Do not apply to irritated skin or if excessive irration develops

Do not bandage

Wash hands after use with cool water

Do not use with heating pad or device.

Stop Use and Ask Doctor If:

Stop Use and Ask Doctor If: Condition worsens, or if symtoms persist for more than 7 days, or clear up and reoccur.

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 accidentally ingested, get medicalhelp or contact a Poisan Control Center immediately.

immedaAqueous (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.

Ask A Doctor Before Use If You Have:

Ask a doctor before use if you have Sensitive skin.


Structured Label Content

Uses

Uses:

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Menthol USP 3.5% Topical Analgesic

Warning

WARNING:

For external use only.

Directions

Directions

Adults and children 2 years of age and older:

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

Repeat as necessary but not more than 4 times daily.

Directions:

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.

Other Infirmation: (Other infirmation:)

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

Inactive Ingredients

Inactive Ingredients:

Aqueous (Deionozed filtered 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, FDCYellow #5, Methylparaben, Triethanolamine.

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

When Using this product:

Avoid contact with the eyes or muscous membranes

Do not apply to wounds or damaged skin

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

Do not apply to irritated skin or if excessive irration develops

Do not bandage

Wash hands after use with cool water

Do not use with heating pad or device.

Stop Use and Ask Doctor If:

Stop Use and Ask Doctor If: Condition worsens, or if symtoms persist for more than 7 days, or clear up and reoccur.

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 accidentally ingested, get medicalhelp or contact a Poisan Control Center immediately.

immedaAqueous (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.

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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