MenthoReal-10 Topical Paint Patch Kit

Drug Details [pdf]

MENTHOREAL-10 KIT- lidocaine/menthol patch
Forreal Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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MenthoReal-10 Topical Paint Patch Kit

Active ingredients:

Lidocaine HCL 4%

Menthol 4%

Purpose:

Topical Anesthetic

Uses:

For the temporary relief of pain

Warnings:

For external use

Do not use:

More than 1 patch on your body at a time or on cut, iritated or swollen skin.
On puncture wounds
For more than 1 week without consulting a doctor

When using this product:

Use only as directed. Read and follow all directions and warnings on this label.
Rare cases of serious burns have been reported with products of this type.
Do not apply to wounds or damaged, broken or irritated skin.
Do not allow contact with the eyes and mucous membranes.
Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
Do not use at the same time as other topical analgesics.
Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if:

Condition worsens
Redness is present
Irritation developes
Symptoms persist for more than 7 days or clear up and occur again within a few days.
You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children over 12 years:

Clean and dry the affected area.
Open pouch and remove one patch.
Remove the protective film from the patch and apply patch to the affected area.
Reseal pouch containing unused patches after each use.
Use 1 patch for up to 12 hours.

Children 12 years or younger:

Ask a doctor

Other Information:

Avoid storing product in direct sunlight
Protect product from excessive mositure

Other Ingredients:

Acrylic Adhesive

Questions or comments? 877-367-3250

Packaged For:

Forreal Pharmaceuticals LLC

Royal Oak, MI 48067

NDC: 81877-510-10

QTY: 10 Articulated patches (5 per Resealable Pouch) x 2

label

MENTHOREAL-10 KIT
lidocaine/menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81877-510(NDC: 70512-013)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ACRYLIC ACID (UNII: J94PBK7X8S)

Product Characteristics
Color		Score
Shape	RECTANGLE (White flexible patch)	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81877-510-10	2 in 1 BOX	02/01/2021	09/19/2022
1		1 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/01/2021	09/19/2022

Labeler - Forreal Pharmaceuticals (118029197)

Revised: 9/2022

Document Id: 3ac2630c-af78-4f7b-a496-f3e816ac5f64

Set id: cdb534a4-e392-21fc-e053-2995a90adae9

Version: 3

Effective Time: 20220919

MenthoReal-10 Topical Paint Patch Kit

MenthoReal-10 Kit by

Drug Labeling and Warnings

Drug Details [pdf]

MenthoReal-10 Topical Paint Patch Kit