Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 05c6b95a-aeb6-4234-97c7-8d77eccb38d8
Route
TRANSDERMAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g) Camphor (synthetic) (3 g)
Inactive Ingredients
Angelica Dahurica Root Butylated Hydroxytoluene Cinnamon Oil Dipsacus Asper Root Dragon's Blood Drynaria Fortunei Root Gardenia Jasminoides Fruit Ginger Lanolin Light Mineral Oil Lonicera Japonica Flower Methyl Salicylate Myrrh Natural Latex Rubber Nepeta Tenuifolia Flowering Top Petrolatum Polyisobutylene (800000 Mw) Rheum Officinale Root Rosin Safflower Saposhnikovia Divaricata Root Senegalia Catechu Wood Taraxacum Mongolicum Whole Zanthoxylum Nitidum Root Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-31

Description

Active ingredients Menthol 5% Camphor 3%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

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

■ arthritis

■ strains

■ simple backache

■ bruises

■ sprains

Dosage and Administration

Directions

■ Adults and children 2 years of age and older: Cut to desired size, remove clear backing, and apply to affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: Do not use, consult a doctor.

Description

Active ingredients Menthol 5% Camphor 3%

Section 44425-7

Other information

■ 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 childrento avoid accidental poisoning. 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

■ when using for pain of arthritis if:

   ■ 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

Section 50570-1

Do not use

■ on wounds

■ on damaged or irritated skin

■ if excessive irritation develops

■ otherwise than as directed, to do so may be dangerous

Section 51727-6

Inactive ingredients

angelica dahurica root, butylated hydroxytoluene, cinnamon oil, dipsacus asper root, dragon's blood, drynaria fortunei root, gardenia jasminoides fruit, ginger, lanolin, light mineral oil, lonicera japonica flower, methyl salicylate, myrrh, natural latex rubber, nepeta tenuifolia flowering top, petrolatum, polyisobutylene, rheum officinale root, rosin, safflower, saposhnikovia divaricata root, senegalia catechu wood, taraxacum mongolicum whole, zanthoxylum nitidum root and zinc oxide.

Section 51945-4

WU YANG BRAND PAIN RELIEVING MEDICATED PLASTER

External Analgesic

NDC 55614-700-01

Large Pain Relief Patches

10 Plasters

Each plaster 3.9 x 11 inches (10 x 28 cm) - 1 Plaster per pouch

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

Menthol 5%

Camphor 3%


Structured Label Content

Indications and Usage (34067-9)

Uses

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

■ arthritis

■ strains

■ simple backache

■ bruises

■ sprains

Dosage and Administration (34068-7)

Directions

■ Adults and children 2 years of age and older: Cut to desired size, remove clear backing, and apply to affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: Do not use, consult a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

■ 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 childrento avoid accidental poisoning. 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

■ when using for pain of arthritis if:

   ■ 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

Section 50570-1 (50570-1)

Do not use

■ on wounds

■ on damaged or irritated skin

■ if excessive irritation develops

■ otherwise than as directed, to do so may be dangerous

Section 51727-6 (51727-6)

Inactive ingredients

angelica dahurica root, butylated hydroxytoluene, cinnamon oil, dipsacus asper root, dragon's blood, drynaria fortunei root, gardenia jasminoides fruit, ginger, lanolin, light mineral oil, lonicera japonica flower, methyl salicylate, myrrh, natural latex rubber, nepeta tenuifolia flowering top, petrolatum, polyisobutylene, rheum officinale root, rosin, safflower, saposhnikovia divaricata root, senegalia catechu wood, taraxacum mongolicum whole, zanthoxylum nitidum root and zinc oxide.

Section 51945-4 (51945-4)

WU YANG BRAND PAIN RELIEVING MEDICATED PLASTER

External Analgesic

NDC 55614-700-01

Large Pain Relief Patches

10 Plasters

Each plaster 3.9 x 11 inches (10 x 28 cm) - 1 Plaster per pouch

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

Menthol 5%

Camphor 3%


Advanced Ingredient Data


Raw Label Data

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