Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 0f269a41-4b56-4e22-b9cb-17d99bf76a57
Route
TRANSDERMAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.1 g) Menthol (2.6 g)
Inactive Ingredients
Ocimum Gratissimum Leaf Oil Butylated Hydroxytoluene Cinnamon Oil Saposhnikovia Divaricata Root Angelica Dahurica Root Ginger Lanolin Natural Latex Rubber Petrolatum Rosin Safflower Nepeta Tenuifolia Flowering Top Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Active Ingredients Camphor 3.1% Menthol 2.6%


Medication Information

Warnings and Precautions

Warnings

For external use only



Allergy alert:
This product contains natural rubber latex which may cause allergic reactions.

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and Administration

Directions

■ adults and children 2 years of age and older: remove the protective film from the patch. Apply to affected area not more than 3 to 4 times daily.

■ children under 2 years of age: consult your physician

Description

Active Ingredients Camphor 3.1% Menthol 2.6%

Section 34084-4

Report any unexpected side effectsfrom the use of this product to the FDA MedWatch Program.

Section 44425-7

Other information

■ keep patches tightly closed in the zip-lock pouch

■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ excessive irritation of the skin develops

■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

■ when using for pain of arthritis:

   ■ pain persists for more than 10 days

   ■ redness is present

   ■ in conditions affecting children under 12 years of age

Section 50567-7

When using this product

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

Section 50568-5

Ask a doctor or pharmacist before use if you have

■ any concerns about using this product

Section 50570-1

Do not use■ on irritated or damaged skin

■ on wounds

■ if you are allergic to any ingredient in this product

Section 51727-6

Inactive ingredients

Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film.

Section 51945-4

EXTRA STRENGTH HUA TUO PAIN RELIEF PATCH

NDC 55614-630-01

An effective herbal patch for the relief of aches and pains from muscles, strains, arthritis, backache, joints, bruises, sprains.

6 Patches

Each Patch 7 x 10 cm (2.75 x 4 in)

Apply for 12 Hours



Section 53413-1

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

■ you may also report serious side effects to this phone number

Section 55105-1

Purpose

External Analgesic

External Analgesic

Section 55106-9

Active Ingredients

Camphor 3.1%

Menthol 2.6%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and Administration (34068-7)

Directions

■ adults and children 2 years of age and older: remove the protective film from the patch. Apply to affected area not more than 3 to 4 times daily.

■ children under 2 years of age: consult your physician

Warnings and Precautions (34071-1)

Warnings

For external use only



Allergy alert:
This product contains natural rubber latex which may cause allergic reactions.

Section 34084-4 (34084-4)

Report any unexpected side effectsfrom the use of this product to the FDA MedWatch Program.

Section 44425-7 (44425-7)

Other information

■ keep patches tightly closed in the zip-lock pouch

■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ excessive irritation of the skin develops

■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

■ when using for pain of arthritis:

   ■ pain persists for more than 10 days

   ■ redness is present

   ■ in conditions affecting children under 12 years of age

Section 50567-7 (50567-7)

When using this product

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you have

■ any concerns about using this product

Section 50570-1 (50570-1)

Do not use■ on irritated or damaged skin

■ on wounds

■ if you are allergic to any ingredient in this product

Section 51727-6 (51727-6)

Inactive ingredients

Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film.

Section 51945-4 (51945-4)

EXTRA STRENGTH HUA TUO PAIN RELIEF PATCH

NDC 55614-630-01

An effective herbal patch for the relief of aches and pains from muscles, strains, arthritis, backache, joints, bruises, sprains.

6 Patches

Each Patch 7 x 10 cm (2.75 x 4 in)

Apply for 12 Hours



Section 53413-1 (53413-1)

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

■ you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

External Analgesic

External Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Camphor 3.1%

Menthol 2.6%


Advanced Ingredient Data


Raw Label Data

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