PAINBLOC24 PROWOMEN WOMENS DISCOMFORTS MENTHOL PAIN AND SLEEP PATCH- menthol 6% patch 
VIZURI HEALTH SCIENCES LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Menthol unspecified 6%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Warnings

For external use only

When using this product

  • use only as directed
  • consult your doctor before use if using any medications or supplements that contain any of these same ingredients
  • do not bandage tightly
  • do not use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • do not use at the same time as other topical analgesics

Stop use and ask a doctor if

  • condition worsens
  • redness persists, spreads or becomes tender
  • symptoms last more than 7 days or clear up and occur again within a few days
  • you experience burning swelling or blistering where applied

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults over 18 years:

Children under 18 years: consult a doctor

Inactive Ingredients

Acrylic adhesive, arnica montana flower extract, chamomile, d-limonene, dipropylene glycol, gamma-aminobutyric acid (GABA), hemp oil, l-theanine, lavender, magnesium chloride, melatonin, passionflower, polysorbate 80, tocopheryl acetate (Vitamin E), white curcumin

Questions

Call 855-438-3944

Other Information

Store in a cool, dry place at room temperature

Product label

image descriptionimage description

PAINBLOC24 PROWOMEN WOMENS DISCOMFORTS MENTHOL PAIN AND SLEEP PATCH 
menthol 6% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71226-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CHAMOMILE (UNII: FGL3685T2X)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
THEANINE (UNII: 8021PR16QO)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MELATONIN (UNII: JL5DK93RCL)  
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CURCUMIN (UNII: IT942ZTH98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71226-004-011 in 1 CARTON01/25/2022
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/25/2022
Labeler - VIZURI HEALTH SCIENCES LLC (052129499)
Establishment
NameAddressID/FEIBusiness Operations
Shawsheen Rubber Co.001051275manufacture(71226-004)

Revised: 1/2022
Document Id: d53fdd9a-6553-3573-e053-2995a90abeb0
Set id: fc79795f-25ce-4d06-88f6-5b1e4bf39815
Version: 1
Effective Time: 20220110
 
VIZURI HEALTH SCIENCES LLC