SPL v2
SPL
SPL Set ID a025b97d-55a2-4abf-a6f4-3b989e85f7bc
Route
TOPICAL
Published
Effective Date 2020-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (50 g) Camphor (synthetic) (5 g)
Inactive Ingredients
Clove Oil Cinnamon Oil Citronella Oil Thyme Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-27

Description

Active ingredient Camphor 5% Methyl salicylate 50%


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 ingredient Camphor 5% Methyl salicylate 50%

Section 34084-4

Report any unexpected side effects from 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 children to 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 Clove oil, cinnamon oil, citronella oil, and thyme oil.

Section 51945-4

HAK KWAI PAIN RELIEVING OIL

Methyl Salicylate and Camphor

NDC 55614-710-01

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

Section 55106-9

Active ingredient Camphor 5% Methyl salicylate 50%


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 effects from 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 children to 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 Clove oil, cinnamon oil, citronella oil, and thyme oil.

Section 51945-4 (51945-4)

HAK KWAI PAIN RELIEVING OIL

Methyl Salicylate and Camphor

NDC 55614-710-01

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

Section 55106-9 (55106-9)

Active ingredient Camphor 5% Methyl salicylate 50%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)