ValleMent Drug Facts

Vallement Flex by

Drug Labeling and Warnings

Vallement Flex by is a Otc medication manufactured, distributed, or labeled by PLUM VALLEY PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VALLEMENT FLEX- lidocaine/menthol patch 
PLUM VALLEY PHARMA LLC

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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ValleMent
Drug Facts

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? Toll Free: 866-248-1553

Packaged For:

Plum Valley Pharma, LLC

Dearborn, MI 48120 USA

Questions and Information please call

Toll Free: 866-248-1553

VALLEMENT FLEX 
lidocaine/menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82226-150
Route of Administration	TOPICAL

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82226-150-05	1 in 1 BOX	05/18/2022	06/30/2022
1		5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/18/2022	06/30/2022

Labeler - PLUM VALLEY PHARMA LLC (118243219)

Revised: 7/2022

Document Id: 2a9562d7-bd6d-44c1-8fc2-087225ba632e

34390-5

Set id: 1ebb179a-aa0e-4ace-a1f6-8c25a88e8264

Version: 2

Effective Time: 20220704