ACUTENS (as PLD) - KANJO - HEMP PAIN RELIEF GEL (80551-102) - DELIST

HEMP PAIN RELIEF by

Drug Labeling and Warnings

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

Drug Details [pdf]

HEMP PAIN RELIEF- menthol gel 
ACUTENS, INC.

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ACUTENS (as PLD) - KANJO - HEMP PAIN RELIEF GEL (80551-102) - 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

WATER, DENATURED DEHYDRATED ALCOHOL 40B, ARNICA MONTANA (ARNICA) FLOWER EXTRACT, PROPYLENE GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, ALOE BARBADENSIS LEAF JUICE, PYRIDOXINE HCL CRYSTALLINE (B6), METHYLSULFONYLMETHANE (MSM) CANNABIS SATIVA SEED OIL

OTHER INFORMATION

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

QUESTIONS OR COMMENTS

(917) 745-3082

HEMP PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80551-102
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
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80551-102-04	113 g in 1 TUBE; Type 0: Not a Combination Product	07/20/2021	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/20/2021	12/31/2023

Labeler - ACUTENS, INC. (051133165)

Revised: 3/2024

Document Id: 14ac7580-ca35-dd19-e063-6394a90ab81d

34390-5

Set id: 9455281e-8fbf-4619-998b-7ac526ba08b9

Version: 6

Effective Time: 20240327