Principal Display Panel

Principal Display Panel
SPL v1
SPL
SPL Set ID 12daded2-c5f6-97cc-e063-6294a90aa6ee
Route
TOPICAL
Published
Effective Date 2022-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Capsaicin 0.0325%


Medication Information

Warnings and Precautions

For External Use Only

Indications and Usage

For the temporary relief of joint pain and muscle pain associated with: Arthritis Simple Backache Muscle Sprains Muscle Strains

Dosage and Administration

Ad ults and Children 12 Years of Age and Older: Clean and dry the affected area Apply product directly to your skin, up to 4 times daily affected area Wash hands immediately after use Children Under 12 Years of Age : Consult physician

Description

Capsaicin 0.0325%

Section 42229-5

Store in a cool, dry place with lid tightly closed If the tamper-evident foil seal is not intact, do not use

Section 44425-7

Keep away from excessive heat or open flame

Section 50565-1

If ingested seek medical help or contact a Poison Control Center immediately

Section 50567-7

Avoid contact with eyes and mucus membranes

Section 50569-3

Conditions worsens Excessive skin irritation develops Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

Section 50570-1

On damaged, irritated, or infected skin With a bandage or heating pad If you are allergic to any ingredients in this product

Section 51727-6

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

Section 51945-4

232

Section 53413-1

[email protected]

Section 53414-9

Ask a health professional before use.

Section 55105-1

Counterirritant

Section 55106-9

Capsaicin 0.0325%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of joint pain and muscle pain associated with: Arthritis Simple Backache Muscle Sprains Muscle Strains

Dosage and Administration (34068-7)

Ad ults and Children 12 Years of Age and Older: Clean and dry the affected area Apply product directly to your skin, up to 4 times daily affected area Wash hands immediately after use Children Under 12 Years of Age : Consult physician

Warnings and Precautions (34071-1)

For External Use Only

Section 42229-5 (42229-5)

Store in a cool, dry place with lid tightly closed If the tamper-evident foil seal is not intact, do not use

Section 44425-7 (44425-7)

Keep away from excessive heat or open flame

Section 50565-1 (50565-1)

If ingested seek medical help or contact a Poison Control Center immediately

Section 50567-7 (50567-7)

Avoid contact with eyes and mucus membranes

Section 50569-3 (50569-3)

Conditions worsens Excessive skin irritation develops Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

Section 50570-1 (50570-1)

On damaged, irritated, or infected skin With a bandage or heating pad If you are allergic to any ingredients in this product

Section 51727-6 (51727-6)

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

Section 51945-4 (51945-4)

232

Section 53413-1 (53413-1)

[email protected]

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Counterirritant

Section 55106-9 (55106-9)

Capsaicin 0.0325%


Raw Label Data

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