Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 17552943-4f11-42d6-ad41-fbc53f2bbd9a
Routes
TRANSDERMAL PERCUTANEOUS
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (5.6 g) Menthol
Inactive Ingredients
Zanthoxylum Nitidum Root Alcohol Polygonum Cuspidatum Whole Cynanchum Paniculatum Root Water Zedoary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-06-01 Until 2030-06-01

Description

Active Ingredients Camphor 5.6% Menthol 5.6%


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable

Keep away from fire or flame

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 Ingredients Camphor 5.6% Menthol 5.6%

Section 34084-4

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

Section 44425-7

Other information

■ keep container tightly closed

■ store at room temperature under 86°F (30°C)

Section 50565-1

Keep out of reach of childrento avoid accidental poisoning.

If swallowed, get medical hep 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 develops

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

■ 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

Section 51727-6

Inactive Ingredients

Alcohol, Japanese knotweed (Polygonum cuspidatum Siebold & Zucc.) rhizome, paniculate swallowwort [Pycnostelma paniculatum (Bge.) K. Schum.] root, shin-leaf prickly ash [Zanthoxylum nitidum (Roxb.) DC.] root, water, zedoary rhizome.

Section 51945-4

ZHENG GU SHUI

NDC 59321-055-01

EXTERNAL ANALGESIC LOTION

3.4 FL OZ (100 mL)

Section 53413-1

Questions or Comments? (888) 221-3496M-F 9 am to 5 pm

Section 55105-1

Purpose

External Analgesic

External Analgesic

Section 55106-9

Active Ingredients

Camphor 5.6%

Menthol 5.6%


Structured Label Content

Indications and Usage (34067-9)

Uses

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

■ 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

Flammable

Keep away from fire or flame

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 container tightly closed

■ store at room temperature under 86°F (30°C)

Section 50565-1 (50565-1)

Keep out of reach of childrento avoid accidental poisoning.

If swallowed, get medical hep 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 develops

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

■ 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

Section 51727-6 (51727-6)

Inactive Ingredients

Alcohol, Japanese knotweed (Polygonum cuspidatum Siebold & Zucc.) rhizome, paniculate swallowwort [Pycnostelma paniculatum (Bge.) K. Schum.] root, shin-leaf prickly ash [Zanthoxylum nitidum (Roxb.) DC.] root, water, zedoary rhizome.

Section 51945-4 (51945-4)

ZHENG GU SHUI

NDC 59321-055-01

EXTERNAL ANALGESIC LOTION

3.4 FL OZ (100 mL)

Section 53413-1 (53413-1)

Questions or Comments? (888) 221-3496M-F 9 am to 5 pm

Section 55105-1 (55105-1)

Purpose

External Analgesic

External Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Camphor 5.6%

Menthol 5.6%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)