PAINFIX RESTORE- menthol patch 
PainFix 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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PainFix Restore Patch

Drug Facts

Active Ingredients

Menthol 7%

Purpose

Topical analgesic

Uses

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

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.

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

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

Other Information

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

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.

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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.

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Made in USA

Manufactured for PainFix LLC
195 Plymouth Street, Suite 404
Brooklyn, New York 11201

Packaging

Patch-008

PAINFIX RESTORE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72749-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM70 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ANGELICA ANOMALA ROOT (UNII: 5YP3GQ626F)  
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
CINNAMOMUM CAMPHORA RESIN (UNII: J3614D61GX)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
CITRUS RETICULATA WHOLE (UNII: O0OX7CMF92)  
MYRRH (UNII: JC71GJ1F3L)  
TURMERIC (UNII: 856YO1Z64F)  
CURCUMA ZEDOARIA ROOT (UNII: 123C43G128)  
DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
PISTACIA LENTISCUS RESIN OIL (UNII: ZJ39788YVA)  
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72749-008-031 in 1 BOX01/07/2022
15 in 1 POUCH
10.18 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/07/2022
Labeler - PainFix LLC (116908667)

Revised: 12/2021
Document Id: 114c8733-c818-49ac-8c1c-8b1c87db6bce
Set id: 19fcfc85-3387-47f0-8c6b-9a1ce7832d36
Version: 1
Effective Time: 20211220
 
PainFix LLC