Label: PAINFIX RESTORE- menthol patch
- NDC Code(s): 72749-008-03
- Packager: PainFix LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 20, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
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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.
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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 exercisesChildren 12 years and younger, ask a health professional
- Other Information
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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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SPL UNCLASSIFIED SECTION
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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.www.painfixbody.com
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Made in USA
Manufactured for PainFix LLC
195 Plymouth Street, Suite 404
Brooklyn, New York 11201 - Packaging
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INGREDIENTS AND APPEARANCE
PAINFIX RESTORE
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72749-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 70 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72749-008-03 1 in 1 BOX 01/07/2022 1 5 in 1 POUCH 1 0.18 g in 1 PATCH; 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 01/07/2022 Labeler - PainFix LLC (116908667)
