Drug Listing

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (10 g) Menthol (15 g) Salicylic Acid (48 g)

Inactive Ingredients

Angelica Biserrata Root Angelica Sinensis Root Chaenomeles Lagenaria Fruit Clematis Chinensis Root Corydalis Yanhusuo Tuber Gentiana Macrophylla Root Lavender Oil Mineral Oil Sinomenium Acutum Stem Taxillus Chinensis Top

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-10-27

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:

■ simple backache

■ arthritis

■ strains

■ bruises

■ sprains

Dosage and Administration

Directions

■ adults and children 3 years of age and older: apply several drops and rub Into the affected area not more than 3 to 4 times daily 

■ children under 3 years of age: consult your physician

Description

Active ingredients Camphor 10% Menthol 15% Methyl salicylate 48%

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 protected from light at 15 to 30 C (59 to 86 F)

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

 ■ 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

■ do not use otherwise than as directed

 ■ 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)

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 wounds

■ on irritated or damaged skin

Section 51727-6

Inactive ingredients

angelica biserrata root, angelica sinensis root, chaenomeles lagenaria fruit, clematis chinensis root, corydalis yanhusuo tuber, gentiana macrophylla root, lavender oil, mineral oil, sinomenium acutum stem, and taxillus chinensis top.

Section 51945-4

QIAN LI ZHUI FENG PAIN RELIEVING OIL

NDC 55614-690-01

EXTERNAL ANALGESIC

1.69 FL OZ (50 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 55105-1

Purpose

External analgesic

External analgesic

External analgesic

Section 55106-9

Active ingredients

Camphor 10%

Menthol 15%

Methyl salicylate 48%

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 3 years of age and older: apply several drops and rub Into the affected area not more than 3 to 4 times daily 

■ children under 3 years of age: consult your physician

Warnings and Precautions (34071-1)

Warnings

For external use only

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 protected from light at 15 to 30 C (59 to 86 F)

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

 ■ 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

■ do not use otherwise than as directed

 ■ 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)

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 wounds

■ on irritated or damaged skin

Section 51727-6 (51727-6)

Inactive ingredients

angelica biserrata root, angelica sinensis root, chaenomeles lagenaria fruit, clematis chinensis root, corydalis yanhusuo tuber, gentiana macrophylla root, lavender oil, mineral oil, sinomenium acutum stem, and taxillus chinensis top.

Section 51945-4 (51945-4)

QIAN LI ZHUI FENG PAIN RELIEVING OIL

NDC 55614-690-01

EXTERNAL ANALGESIC

1.69 FL OZ (50 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 55105-1 (55105-1)

Purpose

External analgesic

External analgesic

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 10%

Menthol 15%

Methyl salicylate 48%

Advanced Ingredient Data

[{"name": "ANGELICA BISERRATA ROOT", "unii": "OJ90180B22", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANGELICA SINENSIS ROOT", "unii": "B66F4574UG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAENOMELES LAGENARIA FRUIT", "unii": "XBC17A15MU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLEMATIS CHINENSIS ROOT", "unii": "8Z18N528CU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORYDALIS YANHUSUO TUBER", "unii": "0TUP42692Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GENTIANA MACROPHYLLA ROOT", "unii": "6559FC0U1B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAVENDER OIL", "unii": "ZBP1YXW0H8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SINOMENIUM ACUTUM STEM", "unii": "BBH96IEM66", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TAXILLUS CHINENSIS TOP", "unii": "QJ523LD71P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "48", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains", "34068-7": "Directions ■ adults and children 3 years of age and older: apply several drops and rub Into the affected area not more than 3 to 4 times daily  ■ children under 3 years of age: consult your physician", "34071-1": "Warnings For external use only", "34084-4": "Report any unexpected side effects from the use of this product to the FDA MedWatch Program", "44425-7": "Other information ■ keep container tightly closed  ■ store protected from light at 15 to 30 C (59 to 86 F)", "50565-1": "Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.", "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", "50567-7": "When using this product ■ do not use otherwise than as directed  ■ 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)", "50568-5": "Ask a doctor or pharmacist before use if you have ■ any concerns about using this product", "50570-1": "Do not use ■ on wounds ■ on irritated or damaged skin", "51727-6": "Inactive ingredients angelica biserrata root, angelica sinensis root, chaenomeles lagenaria fruit, clematis chinensis root, corydalis yanhusuo tuber, gentiana macrophylla root, lavender oil, mineral oil, sinomenium acutum stem, and taxillus chinensis top.", "51945-4": "QIAN LI ZHUI FENG PAIN RELIEVING OIL NDC 55614-690-01 EXTERNAL ANALGESIC 1.69 FL OZ (50 ML)", "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", "55105-1": "Purpose External analgesic External analgesic External analgesic", "55106-9": "Active ingredients Camphor 10% Menthol 15% Methyl salicylate 48%"}