SPL v2
SPL
SPL Set ID b8f8ec7d-7930-4b70-84fb-838992000409
Route
TOPICAL
Published
Effective Date 2021-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (6 g)
Inactive Ingredients
Black Cohosh Chamomile Flower Oil Limonene, (+)- Dipropylene Glycol Eucalyptus Oil Magnesium Chloride Polysorbate 80 .alpha.-tocopherol Acetate Curcumin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-18

Description

Menthol 6%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 6%

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with: • arthritis • simple backache • muscle strains • bruises • sprains

Section 42229-5

NEW!

designed for MENOPAUSAL WOMEN*

SOOTHING PAIN RELIEF WITHOUT PILLS

Backache • Joint Pain

Arthritis Pain

USE UP TO 8 HOURS

NATURAL MENTHOL

INVIGORATING EUCALYPTUS AROMATHERAPY

Thoughtfully Formulated with Ingredients from Nature!

Eucalyptus

Balck Cohosh

Chamomile

Magnesium

PainBloc24® is a registered trademark of Vizuri Health Sciences Consumer Healthcare, Inc.

Distributed by VHS Consumer Healthcare

163 Waterfront Street, Suite 400A

National Harbor, MD 20745

© 2021 Vizuri Health Sciences Consumer Healthcare, Inc.

www.PainBloc24.com

Vizuri® HEALTH SCIENCES CONSUMER HEALTHCARE, INC.

PainBloc24® ProWomen began with the idea of fulfilling the unmet wellness needs of women.

As a woman-led company, we began developing products designed by women for women. We learned, that like ourselves, when it comes to our health and wellness, women want to take fewer pills and use more products that are backed by science, but are inspired by nature.

Our ProWomen products are thoughtfully developed with these goals in mind.

* As women start entering perimenopause and menopause, they often begin experiencing more arthritis and joint pain. We developed a pain patch specially designed for them. With natural menthol and invigorating eucalyptus, our Pain Relief Patch helps relieve backaches, joint and arthritis pain. Use any time for effective, soothing pain relief.

Provides targeted relief right where you need it

4-way stretch fabric is lightweight, thin and breathable

Proprietary dry adhesive technology. Goes on dry & stays in place all day.

So comfortable, you won't even know it's there

FSA/HSA ELIGIBLE

THANK YOU for trying PainBloc24® ProWomen Pain Relief Patches.

Your feedback is important to us and we'd love to hear from you.

Please share your experience with us at at @ ProWomenWellness

Section 50565-1

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

Warnings

For external use only

When using this product

• use only as directed

• 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 or irritation develops

• 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.

Packaging

Directions

Adults and children over 12 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 on affected area no more than 3-4 times daily

Children under 12 years: consult a doctor

Drug Facts

Questions:

Call 855-438-3944

Other Information

Store in a cool, dry place at room temperature

Active Ingredient 

Menthol 6%

Inactive Ingredients

acrylic adhesive, black cohosh, chamomile, d-limonene, dipropylene glycol, eucalyptus, magnesium chloride, polysorbate 80, tocopheryl acetate (Vitamin E), white curcumin


Structured Label Content

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with: • arthritis • simple backache • muscle strains • bruises • sprains

Section 42229-5 (42229-5)

NEW!

designed for MENOPAUSAL WOMEN*

SOOTHING PAIN RELIEF WITHOUT PILLS

Backache • Joint Pain

Arthritis Pain

USE UP TO 8 HOURS

NATURAL MENTHOL

INVIGORATING EUCALYPTUS AROMATHERAPY

Thoughtfully Formulated with Ingredients from Nature!

Eucalyptus

Balck Cohosh

Chamomile

Magnesium

PainBloc24® is a registered trademark of Vizuri Health Sciences Consumer Healthcare, Inc.

Distributed by VHS Consumer Healthcare

163 Waterfront Street, Suite 400A

National Harbor, MD 20745

© 2021 Vizuri Health Sciences Consumer Healthcare, Inc.

www.PainBloc24.com

Vizuri® HEALTH SCIENCES CONSUMER HEALTHCARE, INC.

PainBloc24® ProWomen began with the idea of fulfilling the unmet wellness needs of women.

As a woman-led company, we began developing products designed by women for women. We learned, that like ourselves, when it comes to our health and wellness, women want to take fewer pills and use more products that are backed by science, but are inspired by nature.

Our ProWomen products are thoughtfully developed with these goals in mind.

* As women start entering perimenopause and menopause, they often begin experiencing more arthritis and joint pain. We developed a pain patch specially designed for them. With natural menthol and invigorating eucalyptus, our Pain Relief Patch helps relieve backaches, joint and arthritis pain. Use any time for effective, soothing pain relief.

Provides targeted relief right where you need it

4-way stretch fabric is lightweight, thin and breathable

Proprietary dry adhesive technology. Goes on dry & stays in place all day.

So comfortable, you won't even know it's there

FSA/HSA ELIGIBLE

THANK YOU for trying PainBloc24® ProWomen Pain Relief Patches.

Your feedback is important to us and we'd love to hear from you.

Please share your experience with us at at @ ProWomenWellness

Section 50565-1 (50565-1)

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

Purpose

Topical Analgesic

Warnings

For external use only

When using this product

• use only as directed

• 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 or irritation develops

• 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.

Packaging

Directions

Adults and children over 12 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 on affected area no more than 3-4 times daily

Children under 12 years: consult a doctor

Drug Facts

Questions:

Call 855-438-3944

Other Information

Store in a cool, dry place at room temperature

Active Ingredient 

Menthol 6%

Inactive Ingredients (Inactive ingredients)

acrylic adhesive, black cohosh, chamomile, d-limonene, dipropylene glycol, eucalyptus, magnesium chloride, polysorbate 80, tocopheryl acetate (Vitamin E), white curcumin


Advanced Ingredient Data


Raw Label Data

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