Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 1ba3c31b-2737-4b55-a0ea-90013a1d8cf4
Route
TOPICAL
Published
Effective Date 2022-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g) Camphor (synthetic) (4 g)
Inactive Ingredients
Angelica Dahurica Root Angelica Pubescens Root Camellia Oil Carthamus Tinctorius Flower Bud Chimonanthus Praecox Whole Chrysanthemum Indicum Flower Curcuma Involucrata Root Cynanchum Paniculatum Root Drynaria Fortunei Root Gardenia Jasminoides Fruit Ginger Gleditsia Sinensis Fruit Pueraria Montana Var. Lobata Flowering Top Ligusticum Sinense Root Lindera Aggregata Root Mentha Canadensis Whole Notopterygium Incisum Root Paeonia X Suffruticosa Root Bark Rheum Palmatum Root Saposhnikovia Divaricata Root Shellac Syzygium Nervosum Flower Bud Tangerine Peel, Unripe Tangerine Peel Xanthium Strumarium Fruit Zanthoxylum Nitidum Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-06-01 Until 2027-06-01

Description

Active ingredient Menthol 3% Camphor 4%


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 2 years of age and older: Apply to affected area and rub gently. Do not use for more than 4 times a day.

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

Description

Active ingredient Menthol 3% Camphor 4%

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 in a cool 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


■ excessive irritation of the skin 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 50570-1

Do not use

■ on wounds

■ on irritated or damaged skin

Section 51727-6

Inactive ingredients angelica dahurica (bai zhi) root, angelica pubescens (du huo) root, camellia oil, carthamus tinctorius (hong hua) flower bud, chimonanthus praecox (la mei hua) flower, chrysanthemum indicum (yeh chu hua) flower, curcuma involucrata (tu tian qi) root, cynanchum paniculatum (xu chang pu) root, drynaria fortunei (gu sui bu) root, gardenia jasminoides (zhi zi) fruit, ginger (jiang) root, gleditsia sinensis (da zao jiao) fruit, pueraria montana var. lobata (ge hua) flower top, ligusticum sinense (chuan xiong) root, lindera aggergata (wu yao) root, mentha canadensis (bo he) oil, notopterygium incisum (qiang huo) root, paeonia x suffruticosa (mu dan pi) root bark, rheum palmatum (da huang) root, saposhnikovia divaricata (fang feng) root, shellac, syzygium nervosum flower bud, tangerine (qing pi) unripe peel, tangerine (chen pi) peel, xanthium strumarium (cang er zi) fruit, zanthoxylum nitidum (liang mian zhen) root.

Section 51945-4

YULAM DIE DA WAN HUA PAIN RELIEVING OIL

NDC 55614-740-01

EXTERNAL ANALGESIC

1.7 FL OZ (50 ML)



Section 53413-1

Questions or comments? (888) 221-3496M-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 ingredient

Menthol 3%

Camphor 4%


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 2 years of age and older: Apply to affected area and rub gently. Do not use for more than 4 times a day.

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

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 in a cool 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


■ excessive irritation of the skin 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 50570-1 (50570-1)

Do not use

■ on wounds

■ on irritated or damaged skin

Section 51727-6 (51727-6)

Inactive ingredients angelica dahurica (bai zhi) root, angelica pubescens (du huo) root, camellia oil, carthamus tinctorius (hong hua) flower bud, chimonanthus praecox (la mei hua) flower, chrysanthemum indicum (yeh chu hua) flower, curcuma involucrata (tu tian qi) root, cynanchum paniculatum (xu chang pu) root, drynaria fortunei (gu sui bu) root, gardenia jasminoides (zhi zi) fruit, ginger (jiang) root, gleditsia sinensis (da zao jiao) fruit, pueraria montana var. lobata (ge hua) flower top, ligusticum sinense (chuan xiong) root, lindera aggergata (wu yao) root, mentha canadensis (bo he) oil, notopterygium incisum (qiang huo) root, paeonia x suffruticosa (mu dan pi) root bark, rheum palmatum (da huang) root, saposhnikovia divaricata (fang feng) root, shellac, syzygium nervosum flower bud, tangerine (qing pi) unripe peel, tangerine (chen pi) peel, xanthium strumarium (cang er zi) fruit, zanthoxylum nitidum (liang mian zhen) root.

Section 51945-4 (51945-4)

YULAM DIE DA WAN HUA PAIN RELIEVING OIL

NDC 55614-740-01

EXTERNAL ANALGESIC

1.7 FL OZ (50 ML)



Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496M-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 ingredient

Menthol 3%

Camphor 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)