FDA.reportPublic FDA data

PainFix Relief Gel

Manufacturer
PainFix LLC
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:58

Label at a glance#

ProductPainFix Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

temporarily relieves aches and pains of joints and muscles associated with • backache • arthritis • cramps • strains • bruises • sprains

Dosage and administration

Adults and children above 12 years: apply gel to affected area(s) and massage gently until thoroughly absorbed into skin repeat up to 3 to 4 times per day, on an as needed basis after applying, wash hands with soap and water Children 12 years and younger, ask a health professional

Storage and handling

• store in a cool, dry place, away from direct sunlight

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves aches and pains of joints and muscles associated with • backache • arthritis • cramps • strains • bruises • sprains

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children above 12 years:

  • apply gel to affected area(s) and massage gently until thoroughly absorbed into skin
  • repeat up to 3 to 4 times per day, on an as needed basis
  • after applying, wash hands with soap and water

Children 12 years and younger, ask a health professional

Other Information

STORAGE AND HANDLING SECTION

• store in a cool, dry place, away from direct sunlight

Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bambusa Vulgaris (Mastic) Sap Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Cinnamomum Cassia Oil, Citrus Aurantium Dulcis (Orange) Extract, Commiphora Myrrha (Myrrh) Extract, Curcuma Longa (Turmeric) Extract, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, MethylSulfonylmethane (MSM), Polysorbate-20, Propylene Glycol, Rheum Palmatum (Rhubarb) Extract, Scutellaria Baicalensis (Skullcap) Extract, Sesamum Indicum (Sesame) Oil, Sodium Hydroxide, Sorbic Acid, Xanthan Gum, Zingiber Officinale (Ginger) Extract

SPL UNCLASSIFIED SECTION

YOU GOT THIS

Plant-Based

www.painfixbody.com

Made in USA

Manufactured for:
PainFix LLC
Brooklyn, NY 11201

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PainFix-1PainFix-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415975menthol 5 % Topical GelPSN4
415975menthol 0.05 MG/MG Topical GelSCD4
415975menthol 5 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72749-001-002025-01-30C16284748780-1c7ccaba7-1272-fd44-e053-dadaa90aa01bPainFix Relief Gel
72749-001-032025-01-30C16284748780-1c7ccaba7-1272-fd44-e053-dadaa90aa01bPainFix Relief Gel
72749-001-002022-01-11C16284748780-1c7ccaba7-1272-fd44-e053-dadaa90aa01bPainFix Relief Gel
72749-001-002021-07-23C16284748780-1c7ccaba7-1272-fd44-e053-dadaa90aa01bPainFix Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72749-001-00PainFix Relief1 in 1 BOXGEL14
72749-001-00PainFix Relief60 g in 1 TUBEGEL604
72749-001-03PainFix Relief57 g in 1 BOTTLEGEL574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72749-001PAINFIX RELIEF (MENTHOL) GEL [PAINFIX LLC]4Legacy NDC, 3 package rows20231230_4320db2b-69d0-421b-9890-eeb8c40318ec.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72749-00172749-001-00, 72749-001-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BAMBUSA VULGARIS SAP26W4035XBOIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHINESE CINNAMON OILA4WO0626T5IACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
MYRRHJC71GJ1F3LIACT
TURMERIC856YO1Z64FIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
RHUBARBG280W4MW6EIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
SESAME OILQX10HYY4QVIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT
XANTHAN GUMTTV12P4NEEIACT
GINGERC5529G5JPQIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33506b50-b6dc-43d2-b582-16d8144af4b34320db2b-69d0-421b-9890-eeb8c40318ec2023-12-28WarningsExact identifier
spl id: 33506b50-b6dc-43d2-b582-16d8144af4b3
spl set id: 4320db2b-69d0-421b-9890-eeb8c40318ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.