ACUTENS (as PLD) - KANJO - HEMP PAIN RELIEF ROLLER (80551-103) - DELIST

HEMP PAIN RELIEF ROLLER by

Drug Labeling and Warnings

HEMP PAIN RELIEF ROLLER by is a Otc medication manufactured, distributed, or labeled by ACUTENS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEMP PAIN RELIEF ROLLER- menthol solution 
ACUTENS, INC.

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ACUTENS (as PLD) - KANJO - HEMP PAIN RELIEF ROLLER (80551-103) - DELIST

ACTIVE INGREDIENTS

MENTHOL 5%

PURPOSE

TOPICAL ANALGESIC

USES

TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLES AND JOINTS.

WARNINGS

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.

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

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

DIRECTIONS

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

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

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

QUESTIONS OR COMMENTS

(917) 745-3082

HEMP PAIN RELIEF ROLLER 
menthol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80551-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80551-103-02	70 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	07/21/2021	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/21/2021	12/31/2023

Labeler - ACUTENS, INC. (051133165)

Revised: 3/2024

Document Id: 14bc05b2-d867-763b-e063-6294a90a83cf

34390-5

Set id: 37a4779c-6c8f-4458-9d0e-73907ce1b922

Version: 6

Effective Time: 20240328