FDA.reportPublic FDA data

Pain Relief Gel

Manufacturer
HEMPFUSION, INC. | Universal Packaging Systems, Inc. (DBA Paklab)
Effective date
2021-03-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:03

Label at a glance#

ProductPain Relief Gel
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage and administration

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: consult a doctor.

Storage and handling

Store in a cool dry place away from light

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.5%

Purpose

OTC - PURPOSE SECTION

Menthol 1.5%........Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not bandage tightly
  • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens
  • irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool dry place away from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

water (aqua), glycerin, peppermint (mentha piperita) leaf oil, coco-caprylate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, organic aloe (aloe barbadensis) leaf juice, arnica (arnica montana) flower extract, pepper (capsicum annuum) fruit extract, ginger (zingiber officinale) root extract, organic turmeric (curcuma longa) root oil, organic rosemary (rosmarinus officinalis) leaf oil, black pepper (piper nigrum) fruit oil, clove (syzgium aromaticum) flower oil, jojoba (simmondsia chinensis) esters, lysolecithin, sclerotium gum, ethylhexylglycerin, glucose, pullulan, xanthan gum, glucose oxidase, lactoperoxidase, silica, magnesium sulfate, organic eucalyptus (eucalyptus globulus) leaf oil

Questions or comments?

OTC - QUESTIONS SECTION

Call 877-669-4367 Monday through Friday, 9am-5pm EST.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HempFusion

Pain ReliefGel

Menthol 1.5%

Including moisturizing Arnica, hemp extract with naturally occuring CBD (65mg/bottle) + Terpenes (60mg/bottle) from black pepper and clove & other natural skin moisturizers

U.S. HEMP AUTHORITY CERTIFIED

NON-GMO

ALL SKIN TYPES

50mL (1.69 fl oz)

cartoncarton

bottlebottle

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73672-989-502024-01-30C16284748780-11030e365-05df-111a-e063-dadaa90a10e2Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73672-989-50Pain Relief Gel1 in 1 CARTONGEL13
73672-989-50Pain Relief Gel50 mL in 1 BOTTLEGEL503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73672-989PAIN RELIEF GEL (MENTHOL 1.5%) GEL [HEMPFUSION, INC.]3Legacy NDC, 2 package rows20210319_bb270f7b-e5b6-41a4-e053-2995a90a559f.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73672-98973672-989-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
HEMPTD1MUT01Q7IACT
PEPPERMINT OILAV092KU4JHIACT
ALOEV5VD430YW9IACT
ROSEMARY OIL8LGU7VM393IACT
CLOVE OIL578389D6D0IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
WATER059QF0KO0RIACT
CAPSICUM00UK7646FGIACT
GINGERC5529G5JPQIACT
TURMERIC OIL6KGS8SP16UIACT
MYELOPEROXIDASEJQZ6YM58U5IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BLACK PEPPER OILU17J84S19ZIACT
BETASIZOFIRAN2X51AD1X3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
PULLULAN8ZQ0AYU1TTIACT
XANTHAN GUMTTV12P4NEEIACT
GLUCOSE OXIDASE0T8392U5N1IACT
EUCALYPTUS OIL2R04ONI662IACT
COCO-CAPRYLATE4828G836N6IACT
LYSOPHOSPHATIDYLCHOLINE, SOYBEANCQD833204ZIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
MENTHOLL7T10EIP3AACTIB

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
bdc694d9-cc93-515d-e053-2a95a90aec0abb270f7b-e5b6-41a4-e053-2995a90a559f2021-03-17WarningsExact identifier
spl id: bdc694d9-cc93-515d-e053-2a95a90aec0a
spl set id: bb270f7b-e5b6-41a4-e053-2995a90a559f

Reported adverse events (FAERS/openFDA)#

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