FDA.reportPublic FDA data

HEMP PAIN RELIEF ROLLER

Manufacturer
ACUTENS, INC.
Effective date
2023-09-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:25:43

Label at a glance#

ProductHEMP PAIN RELIEF ROLLER
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLES AND JOINTS.

Dosage and administration

APPLY TO PAINFUL AREA AND RUB INTO THE SKIN. ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER 2 YEARS OF AGE: CONSULT A DOCTOR.

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 MILD ACHES AND PAINS OF MUSCLES AND JOINTS.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. IF CONDITION WORSENS, OR IF SYMPTOMS PERSISIT FOR MORE THEN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

OTC - DO NOT USE SECTION

DO NOT USE AROUND EYE AREA, ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN, MOUTH GENITALS OR ANY OTHER MUCOUS MEMBRANCE. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. IF IRRITATION DEVELOPS, DISCONTINUE USE.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY TO PAINFUL AREA AND RUB INTO THE SKIN. ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER:

APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER 2 YEARS OF AGE: CONSULT A DOCTOR.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

XANTHAN GUM, WATER, POTASSIUM CETYL PHOSPHATE, PHENETHYL ALCOHOL, MATRICARIA RECUTITA FLOWER EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, GLYCERIN, CAPRYLYL GLYCOL, CANNABIS SATIVA SEED OIL, BOSWELLIA SERRATA GUM, ALOE BARBADEBSIS LEAF JUICE

OTHER INFORMATION

OTHER SAFETY INFORMATION

KEEP CAP TIGHLTY CLOSED. STORE IN A COOL, DRY, DARK PLACE.

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

(917) 745-3082

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Hemp Pain Relief Roller.jpg01b LBL_Hemp Pain Relief Roller.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80551-103-022024-01-30C16284748780-11030e365-0872-111a-e063-dadaa90a10e2ACUTENS - KANJO - HEMP PAIN RELIEF ROLLER

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80551-10380551-103-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
MATRICARIA RECUTITAG0R4UBI2ZZIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
14bc05b2-d867-763b-e063-6294a90a83cf37a4779c-6c8f-4458-9d0e-73907ce1b9222024-03-28WarningsExact identifier
spl set id: 37a4779c-6c8f-4458-9d0e-73907ce1b922

Reported adverse events (FAERS/openFDA)#

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