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

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Menthol 1.5%

Purpose

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

Uses

Uses

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

Warnings

Warnings

For external use only

Directions And Dosage

Directions

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 Label Information

Other information

Store in a cool dry place away from light

Inactive ingredients

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?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemp Fusion Pain Relief Gel 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)

Label Images#

OTC_Pain Relief Gel Carton_Flat__v1.7_00816179029847-page-001
OTC_Pain Relief Gel Carton_Flat__v1.7_00816179029847-page-001
HF__PainRelief--Gel-Label__v1.3--Pantone--Outlined-page-001
HF__PainRelief--Gel-Label__v1.3--Pantone--Outlined-page-001

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#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemp Fusion Pain Relief Gel 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)

Source Document#

Source XML