FDA.reportPublic FDA data

Pain Relief Balm

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 Balm
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muslces 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Menthol 4%...................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muslces 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 apply to wounds or damaged skin
  • do not bandage tightly

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

organic shea (burtyrospermum parkii) butter, organic carnauba (copernicia cerifera) wax, peppermint leaf oil (mentha piperita), organic sunflower (helianthus annuus) seed oil, organic jojoba (simmondsia chinensis) seed oil, organic coconut (cocos nucifera) oil, cetearyl olivate, sorbitan olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, black pepper (piper nigrum) fruit oil (source of terpenes), clove (syzygium aromaticum) flower oil, magnesium sulfate, rosemary (rosmarinus officinalis) extract

OTC - QUESTIONS SECTION

Manufactured for HempFusion

3820 NW 14th Street Suite A & B

Topeka, KS 66618

877.NOW.HEMP (877.669.4367)

hempfusion.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain

Relief

BALM

HempFusion

Menthol 4%

Including hemp extract with naturally occurring CBD (50mg/jar) + Terpenes (45mg/jar) from black pepper and clove & other nautral skin moisturizers

NON-GMO

ALL SKIN TYPES

1.4 oz (40g)

BoxBoxLabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73672-988-402024-01-30C16284748780-11030e365-1ce8-111a-e063-dadaa90a10e2Pain Relief Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73672-988-40Pain Relief Balm40 g in 1 CONTAINERCREAM403
73672-988-40Pain Relief Balm1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73672-988PAIN RELIEF BALM (MENTHOL 4%) CREAM [HEMPFUSION, INC.]3Legacy NDC, 2 package rows20210319_9edfe475-64f9-2a44-e053-2995a90a058b.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73672-98873672-988-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
PEPPERMINT OILAV092KU4JHIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ROSEMARYIJ67X351P9IACT
CARNAUBA WAXR12CBM0EIZIACT
HEMPTD1MUT01Q7IACT
BLACK PEPPER OILU17J84S19ZIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
COCONUT OILQ9L0O73W7LIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
CLOVE OIL578389D6D0IACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML · Source PDF

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
bdc68734-382e-0f6a-e053-2a95a90ae26f9edfe475-64f9-2a44-e053-2995a90a058b2021-03-17WarningsExact identifier
spl id: bdc68734-382e-0f6a-e053-2a95a90ae26f
spl set id: 9edfe475-64f9-2a44-e053-2995a90a058b

Reported adverse events (FAERS/openFDA)#

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