Olu Pain Management Patch

Olu Pain Management Patch
SPL v2
SPL
SPL Set ID 2a41a621-c6f7-5819-e063-6394a90ae67d
Route
CUTANEOUS
Published
Effective Date 2024-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (0.01 g) Lidocaine (0.04 g)
Inactive Ingredients
Tartaric Acid Water Boswellia Serrata Whole Methylparaben Sodium Polyacrylate (8000 Mw) Propylene Glycol Dihydroxyaluminum Aminoacetate Glycerin Ascorbic Acid Alpha-tocopherol Alcohol Arnica Montana Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-24

Description

Lidocaine 4%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 4%

Uses

For the temporary relief of muscle pain and joint pain associated with:

-Backache -Cramps -Soreness -Strains -Discomfort -Neckache

Section 51945-4

Flammable

Keep away from excessive heat or open flame

Warnings:

FOR EXTERNAL USE ONLY

Directions

Adults and Children 12 Years of Age and Older:

-Clean and dry the affected area

-Apply gel pad directly onto skin for up to 12 hours

-Wash hands immediately after use

-Gel pad can be cut into pieces and used on up to 2 body parts at a time

-One application per day is recommended

Do Not Use

-On damaged, irritated, or infected skin

-With a bandage or heating pad

-If you are allergic to any ingredients in this product

-In the eyes, nose, or mouth

-Otherwise as directed

Allergy Alert

Local anesthetics may cause methemoglobinemia. If an allergic reaction occurs, stop use and seek medical attention immediately.

Other Information

-Store in a cool, dry place with pouch tightly closed. Keep from freezing.

-If the tamper-evident foil seal is not intact, do not use

Active Ingredients

Lidocaine 4%

Inactive Ingredients

Arnica Extract, Boswellia Extract, Vitamin C, Vitamin E, Ethyl Alcohol, Propylene Glycol, Glycerol, Sodium Polyacrylate, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Water

Questions Or Comments
When Using This Product

Avoid contact with the eyes, nose, and mouth

Stop Use and Ask Doctor If

-Any of the warnings apply to you

-Excessive skin irritation develops

-Condition worsens

-Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

If Pregnant Or Breastfeeding

Ask a healthcare professional before use

Keep Out of Reach of Children

If ingested, seek medical help or contact Poison Control immediately


Structured Label Content

Uses (USES)

For the temporary relief of muscle pain and joint pain associated with:

-Backache -Cramps -Soreness -Strains -Discomfort -Neckache

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Local Anesthetic

Flammable (FLAMMABLE)

Keep away from excessive heat or open flame

Warnings: (WARNINGS:)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

Adults and Children 12 Years of Age and Older:

-Clean and dry the affected area

-Apply gel pad directly onto skin for up to 12 hours

-Wash hands immediately after use

-Gel pad can be cut into pieces and used on up to 2 body parts at a time

-One application per day is recommended

Do Not Use (DO NOT USE)

-On damaged, irritated, or infected skin

-With a bandage or heating pad

-If you are allergic to any ingredients in this product

-In the eyes, nose, or mouth

-Otherwise as directed

Allergy Alert (ALLERGY ALERT)

Local anesthetics may cause methemoglobinemia. If an allergic reaction occurs, stop use and seek medical attention immediately.

Other Information (OTHER INFORMATION)

-Store in a cool, dry place with pouch tightly closed. Keep from freezing.

-If the tamper-evident foil seal is not intact, do not use

Active Ingredients (ACTIVE INGREDIENTS)

Lidocaine 4%

Inactive Ingredients (INACTIVE INGREDIENTS)

Arnica Extract, Boswellia Extract, Vitamin C, Vitamin E, Ethyl Alcohol, Propylene Glycol, Glycerol, Sodium Polyacrylate, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Water

Questions Or Comments (QUESTIONS OR COMMENTS)
When Using This Product (WHEN USING THIS PRODUCT)

Avoid contact with the eyes, nose, and mouth

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

-Any of the warnings apply to you

-Excessive skin irritation develops

-Condition worsens

-Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

If Pregnant Or Breastfeeding (IF PREGNANT OR BREASTFEEDING)

Ask a healthcare professional before use

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If ingested, seek medical help or contact Poison Control immediately


Advanced Ingredient Data


Raw Label Data

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