SPL v3
SPL
SPL Set ID 53397663-044d-4e48-989b-2c6257af5f84
Route
PERCUTANEOUS
Published
Effective Date 2023-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4.1 g) Menthol
Inactive Ingredients
Reynoutria Japonica Root Securidaca Inappendiculata Root Piper Hancei Top Angelica Pubescens Root Calophyllum Membranaceum Whole Periploca Sepium Root Bark Ardisia Crenata Root Cyathula Officinalis Root Cynanchum Paniculatum Root Kadsura Coccinea Whole Maclura Cochinchinensis Root Clematis Chinensis Root Alcohol Artocarpus Styracifolius Root Curcuma Phaeocaulis Root Eucommia Ulmoides Bark Lasiobema Championii Stem Millettia Pulchra Root Pothos Repens Root Sarcandra Glabra Top Sparganium Stoloniferum Root Spatholobus Suberectus Stem Angelica Dahurica Root Ardisia Gigantifolia Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-04-04 Until 2028-05-01

Description

Active ingredient Menthol 4.1% Camphor 4.1%


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

■ bruises

■ sprains

■ simple backache

Dosage and Administration

Directions

■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: do no use or consult a doctor.

Description

Active ingredient Menthol 4.1% Camphor 4.1%

Section 34084-4

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

Section 44425-7

Other information

■ store at room temperature, 20 to 25 C (68 to 77 F)

Section 50565-1

Keep out of reach of children to avoid accidental poisoning.

If swallowed, get medical hep or contact a Poison Control Center right away.

Do not use otherwise than as directed.

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

■ redness is present

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 irritated or damaged skin

■ sensitive skin

■ with a heating pad

■ if pregnant

■ with, or at the same time as, other external analgesic products

■ if allergic to any ingredients of this product

Section 51727-6

Inactive ingredients Alcohol, angelica dahurice root, angelica pubescens root, ardisia crenata root, ardisia gigantifolia root, artocarpus styracifolius root, calophyllum membranaceum whole, clematis chinensis root, curcuma phaeocaulis root, cyathulae officinalis root, cynanchum paniculatum root, eucommia ulmoides bark, kadsura coccinea whole, lasiobema championii stem, maclura cochinensis root, millettia pulchra root, periploca sepium root bark, piper hancei top, pothos repens root, reynoutria japonica root, sarcandra glabra top, securidaca inappendiculata root, spargnaium stoloniferum root, and spatholobus suberectus stem.

Section 51945-4

ULTRA STRENGTH ZHENG GU SHUI

MENTHOL AND CAMPHOR

NDC 59321-056-02

EXTERNAL ANALGESIC

3.0 FL OZ (88 ML)

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 53414-9

If pregnant, ask a health professional before use.

Section 55105-1

Purpose

External analgesic

External analgesic

Section 55106-9

Active ingredient

Menthol 4.1%

Camphor 4.1%


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

■ bruises

■ sprains

■ simple backache

Dosage and Administration (34068-7)

Directions

■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

■ Children under 2 years of age: do no use or consult a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 34084-4 (34084-4)

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

Section 44425-7 (44425-7)

Other information

■ store at room temperature, 20 to 25 C (68 to 77 F)

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning.

If swallowed, get medical hep or contact a Poison Control Center right away.

Do not use otherwise than as directed.

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

■ redness is present

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 irritated or damaged skin

■ sensitive skin

■ with a heating pad

■ if pregnant

■ with, or at the same time as, other external analgesic products

■ if allergic to any ingredients of this product

Section 51727-6 (51727-6)

Inactive ingredients Alcohol, angelica dahurice root, angelica pubescens root, ardisia crenata root, ardisia gigantifolia root, artocarpus styracifolius root, calophyllum membranaceum whole, clematis chinensis root, curcuma phaeocaulis root, cyathulae officinalis root, cynanchum paniculatum root, eucommia ulmoides bark, kadsura coccinea whole, lasiobema championii stem, maclura cochinensis root, millettia pulchra root, periploca sepium root bark, piper hancei top, pothos repens root, reynoutria japonica root, sarcandra glabra top, securidaca inappendiculata root, spargnaium stoloniferum root, and spatholobus suberectus stem.

Section 51945-4 (51945-4)

ULTRA STRENGTH ZHENG GU SHUI

MENTHOL AND CAMPHOR

NDC 59321-056-02

EXTERNAL ANALGESIC

3.0 FL OZ (88 ML)

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 53414-9 (53414-9)

If pregnant, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

External analgesic

External analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 4.1%

Camphor 4.1%


Advanced Ingredient Data


Raw Label Data

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