Pain Relief Cream

Pain Relief Cream
SPL v1
SPL
SPL Set ID 10271c82-2e01-e975-e063-6394a90a8160
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Lecithin, Soybean Aloe Water Propylene Glycol Alpha-tocopherol Acetate Menthol Carbomer Homopolymer, Unspecified Type Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30

Description

Pain Relief Cream


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration

Adults and children 2 years of age and older: Apply to affected area notmore than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Description

Pain Relief Cream

Section 42229-5

Pain Relief Cream

Section 44425-7

Protect the product in this container from excessive heat and direct sun.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

Section 50566-9

rash or irritation develops and lasts.

condition worsens, or if symptoms persist for more than 7 days or dearup and occur again within a few days.

Section 50567-7

Avoid contact with the eyes.

Do notbandage tightly.

Section 50570-1

on damaged or broken skin.

Section 51727-6

Aloe barbadebsis leaf juice (Aloe vera)

Water

Lecithin (Soybean)

Propylene Glycol

Tocopheryl Acetate

Carbomer

Menthol

Triethanolamine

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Adults and children 2 years of age and older: Apply to affected area notmore than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Pain Relief Cream

Section 44425-7 (44425-7)

Protect the product in this container from excessive heat and direct sun.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

Section 50566-9 (50566-9)

rash or irritation develops and lasts.

condition worsens, or if symptoms persist for more than 7 days or dearup and occur again within a few days.

Section 50567-7 (50567-7)

Avoid contact with the eyes.

Do notbandage tightly.

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

Aloe barbadebsis leaf juice (Aloe vera)

Water

Lecithin (Soybean)

Propylene Glycol

Tocopheryl Acetate

Carbomer

Menthol

Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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