PAINBLOC24 PROWOMEN WOMENS DISCOMFORTS MENTHOL PAIN AND SLEEP PATCH- menthol 6% patch

PainBloc24 ProWomen Womens Discomforts Menthol Pain and Sleep Patch by

Drug Labeling and Warnings

PainBloc24 ProWomen Womens Discomforts Menthol Pain and Sleep Patch by is a Otc medication manufactured, distributed, or labeled by VIZURI HEALTH SCIENCES LLC, Shawsheen Rubber Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• Simple backache
• Muscle strains
• Arthritis
• Bruises
• Sprains

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:

• clean and dry affected area
• trim excessive hair for better adhesion
• open pouch and remove patch
• remove backing from patch by grasping both ends and pulling backing apart
• peel off one half of backing and place patch onto affected area
• peel off other half of backing and press and smooth onto skin
• use patch as needed for up to 8 hours. Do not remove when wet or directly after showering or bathing. Allow patch to dry and then slowly remove.
• use one patch at a time for up to 8 hours

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

INGREDIENTS AND APPEARANCE

PAINBLOC24 PROWOMEN WOMENS DISCOMFORTS MENTHOL PAIN AND SLEEP PATCH 
menthol 6% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71226-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71226-004-01	1 in 1 CARTON	01/25/2022
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/25/2022

Labeler - VIZURI HEALTH SCIENCES LLC (052129499)

Establishment
Name	Address	ID/FEI	Business Operations
Shawsheen Rubber Co.		001051275	manufacture(71226-004)