drug facts

drug facts
SPL v6
SPL
SPL Set ID 4842c6ec-7823-4f6b-afc4-258fce2c2391
Route
topical
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.8 g) camphor (synthetic)
Inactive Ingredients
alcohol alisma plantago-aquatica subsp. orientale root angelica dahurica root angelica sinensis root atractylodes lancea root atractylodes macrocephala root cinnamomum cassia twig citrus aurantium fruit cullen corylifolium fruit cuscuta chinensis seed cyperus rotundus tuber dioscorea villosa tuber erycibe obtusifolia stem fennel seed frankincense gleditsia sinensis fruit ligusticum sinense subsp. chuanxiong root myrrh incised notopterygium rhizome or root (notopterygium franchetii) paeonia x suffruticosa root bark panax notoginseng root polygonatum sibiricum root polysorbate 80 prunus armeniaca seed water tangerine peel

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-11-25

Description

Active ingredient Menthol 2.8% Camphor 2.8%


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable:Keep away from fire or flame.

Active Ingredient

Active ingredient

Menthol 2.8%

Camphor 2.8%

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 not more than 3 to 4 times daily.

children under 2 years of age: consult your physician

Description

Active ingredient Menthol 2.8% Camphor 2.8%

Section 34084-4

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

Section 44425-7

Other information

cap bottle tightly

store at room temperature, away from heat

Section 50565-1

Keep out of reach of children.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

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 irritated or damaged skin

on wounds

if you are allergic to any ingredient in this product

Section 51727-6

Inactive ingredients

Alcohol, alisma plantago-aquatica subsp. orientale root , angelica dahurica root, angelica sinensis root, atractylodes lancea root, atractylodes macrocephala root, cinnamomum cassia twig, citrus aurantium fruit, cullen corylifolium fruit, cuscuta chinensis seed, cyperus rotundus tuber, dioscorea villosa tuber, erycibe obtusifolia stem, fennel seed, frankincense, gleditsia sinensis fruit, ligusticum sinense subsp. chuanxiong root, myrrh, notopterygium franchetii root, paeonia x suffruticosa root bark, panax notoginseng root, polygonatum sibiricum root, polysorbate 80, prunus armeniaca seed, purified water, and tangerine peel.

Section 51945-4

Lung Choy Shung Pain Relief Liquid

External Analgesic

NDC 55614-600-01

Menthol and Camphor

6.76 fl oz (200 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


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 ingredient

Menthol 2.8%

Camphor 2.8%

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 not more than 3 to 4 times daily.

children under 2 years of age: consult your physician

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

cap bottle tightly

store at room temperature, away from heat

Section 50565-1 (50565-1)

Keep out of reach of children.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

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 irritated or damaged skin

on wounds

if you are allergic to any ingredient in this product

Section 51727-6 (51727-6)

Inactive ingredients

Alcohol, alisma plantago-aquatica subsp. orientale root , angelica dahurica root, angelica sinensis root, atractylodes lancea root, atractylodes macrocephala root, cinnamomum cassia twig, citrus aurantium fruit, cullen corylifolium fruit, cuscuta chinensis seed, cyperus rotundus tuber, dioscorea villosa tuber, erycibe obtusifolia stem, fennel seed, frankincense, gleditsia sinensis fruit, ligusticum sinense subsp. chuanxiong root, myrrh, notopterygium franchetii root, paeonia x suffruticosa root bark, panax notoginseng root, polygonatum sibiricum root, polysorbate 80, prunus armeniaca seed, purified water, and tangerine peel.

Section 51945-4 (51945-4)

Lung Choy Shung Pain Relief Liquid

External Analgesic

NDC 55614-600-01

Menthol and Camphor

6.76 fl oz (200 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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)