Search by Drug Name or NDC

NDC 71226-0004-01 PainBloc24 ProWomen Womens Discomforts Menthol Pain and Sleep Patch 6 g/1 Details

PainBloc24 ProWomen Womens Discomforts Menthol Pain and Sleep Patch 6 g/1

PainBloc24 ProWomen Womens Discomforts Menthol Pain and Sleep Patch is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by VIZURI HEALTH SCIENCES LLC. The primary component is MENTHOL.

Product Information

NDC	71226-0004
Product ID	71226-004_d53fdd9a-6553-3573-e053-2995a90abeb0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PainBloc24 ProWomen Womens Discomforts Menthol Pain and Sleep Patch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol 6%
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	6
Active Ingredient Units	g/1
Substance Name	MENTHOL
Labeler Name	VIZURI HEALTH SCIENCES LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71226-0004-01 (71226000401)

Pricing Information	N/A
NDC Package Code	71226-004-01
Billing NDC	71226000401
Package	1 POUCH in 1 CARTON (71226-004-01) / 5 PATCH in 1 POUCH
Marketing Start Date	2022-01-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fc79795f-25ce-4d06-88f6-5b1e4bf39815 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71226-004-01	1 in 1 CARTON	01/25/2022
1		5 in 1 POUCH; Type 0: Not a Combination Product

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

Labeler - VIZURI HEALTH SCIENCES LLC (052129499)

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

Revised: 1/2022

Document Id: d53fdd9a-6553-3573-e053-2995a90abeb0

Set id: fc79795f-25ce-4d06-88f6-5b1e4bf39815

Version: 1

Effective Time: 20220110