Painfix Restore Patch

Painfix Restore Patch
SPL v1
SPL
SPL Set ID 19fcfc85-3387-47f0-8c6b-9a1ce7832d36
Route
TOPICAL
Published
Effective Date 2022-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (70 mg)
Inactive Ingredients
Aloe Vera Leaf Angelica Anomala Root Arnica Montana Whole Carthamus Tinctorius Flower Bud Cinnamomum Camphora Resin Chinese Cinnamon Citrus Reticulata Whole Myrrh Turmeric Curcuma Zedoaria Root Dragon's Blood Drynaria Fortunei Root Pistacia Lentiscus Resin Oil Rheum Officinale Root Scutellaria Baicalensis Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-07

Description

Menthol 7%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 7%

Uses

Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonitis • cramps • strains • bruises • sprains

Section 42229-5

UNLOCK YOUR BODY

TAKE ME WITH YOU!

I don't belong in the medicine cabinet. Throw me in your purse or gym bag, or take me along when you're exploring the world or pushing your limits. Think of me as a tool to unlock a higher experience for moments that matter in your life.

1. Peel off the transparent layer

2. Place the patch on the affected area. Use as many as you need.

3. Use each patch for up to 15 hours.

4. For best results, use the patch with the exercises in your personalized regimen.

www.painfixbody.com

Welcome to our community.

Share your #UnlockedBody Story:

Made in USA

Manufactured for PainFix LLC

195 Plymouth Street, Suite 404

Brooklyn, New York 11201

Section 50565-1

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

Warnings

Avoid direct contact with eyes. For external use only.

When using this product • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

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

Packaging

Directions

Adults and children above 12 years:

• open pouch and remove patch

• peel off protective backing and carefully apply sticky side to affected area

• if affected area is large, use more than one patch for best results

• use each patch for up to 15 hours

• apply a new patch each day

• cut the patch to fit smaller areas

• for best results, use with recommended exercises

Children 12 years and younger, ask a health professional

Drug Facts

Other Information

Store in a cool, dry place, away from direct sunlight.

Active Ingredients

Menthol 7%

Inactive Ingredients

Acrylic Adhesive, Aloe Vera (Aloe Barbadensis) Extract, Wild Celery (Angelica Anomala) Extract, Arnica (Arnica Montana) Extract, Safflower (Carthamus Tinctorius) Extract, Camphor (Cinnamomum Camphora) Extract, Chinese Cinnamon (Cinnamomum Cassia) Extract, Mandarin Orange (Citrus Reticulata) Extract, Myrrh (Commiphora Molmol) Extract, Turmeric (Curcuma Longa) Extract, White Turmeric (Curcuma zedoaria) Extract, Dragon's Blood (Daemonorops Draco) Extract, Basket Fern (Drynaria Fortunei) Extract, Mastic Sap (Pistacia Lentiscus) Extract, Tibetan Rhubarb (Rheum Officinale) Extract, Baikal Skullcap (Scutellaria Baicalensis) Extract.


Structured Label Content

Uses

Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonitis • cramps • strains • bruises • sprains

Section 42229-5 (42229-5)

UNLOCK YOUR BODY

TAKE ME WITH YOU!

I don't belong in the medicine cabinet. Throw me in your purse or gym bag, or take me along when you're exploring the world or pushing your limits. Think of me as a tool to unlock a higher experience for moments that matter in your life.

1. Peel off the transparent layer

2. Place the patch on the affected area. Use as many as you need.

3. Use each patch for up to 15 hours.

4. For best results, use the patch with the exercises in your personalized regimen.

www.painfixbody.com

Welcome to our community.

Share your #UnlockedBody Story:

Made in USA

Manufactured for PainFix LLC

195 Plymouth Street, Suite 404

Brooklyn, New York 11201

Section 50565-1 (50565-1)

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

Purpose

Topical analgesic

Warnings

Avoid direct contact with eyes. For external use only.

When using this product • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

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

Packaging

Directions

Adults and children above 12 years:

• open pouch and remove patch

• peel off protective backing and carefully apply sticky side to affected area

• if affected area is large, use more than one patch for best results

• use each patch for up to 15 hours

• apply a new patch each day

• cut the patch to fit smaller areas

• for best results, use with recommended exercises

Children 12 years and younger, ask a health professional

Drug Facts

Other Information

Store in a cool, dry place, away from direct sunlight.

Active Ingredients

Menthol 7%

Inactive Ingredients

Acrylic Adhesive, Aloe Vera (Aloe Barbadensis) Extract, Wild Celery (Angelica Anomala) Extract, Arnica (Arnica Montana) Extract, Safflower (Carthamus Tinctorius) Extract, Camphor (Cinnamomum Camphora) Extract, Chinese Cinnamon (Cinnamomum Cassia) Extract, Mandarin Orange (Citrus Reticulata) Extract, Myrrh (Commiphora Molmol) Extract, Turmeric (Curcuma Longa) Extract, White Turmeric (Curcuma zedoaria) Extract, Dragon's Blood (Daemonorops Draco) Extract, Basket Fern (Drynaria Fortunei) Extract, Mastic Sap (Pistacia Lentiscus) Extract, Tibetan Rhubarb (Rheum Officinale) Extract, Baikal Skullcap (Scutellaria Baicalensis) Extract.


Advanced Ingredient Data


Raw Label Data

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