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

Active Ingredient

Active Ingredients

Camphor 5.6%

Menthol 5.6%

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable

Keep away from fire or flame

Active Ingredient (55106-9)

Active Ingredients

Camphor 5.6%

Menthol 5.6%

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.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)