ACUTENS (as PLD) - KANJO - HEMP PAIN RELIEF CREAM (80551-101) - 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- trolamine salicylate cream 
ACUTENS, INC.

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ACUTENS (as PLD) - KANJO - HEMP PAIN RELIEF CREAM (80551-101) - DELIST

ACTIVE INGREDIENTS

Triethanolamine Salicylate 10%

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

ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, ZANTHOXYLUM AMERICANUM BARK EXTRACT, WATER, STEARYL ALCOHOL, SALIX ALBA (WILLOW) BARK EXTRACT, PROPYLENE GLYCOL, POLYSORBATE 60, PINUSPINASTER BARK/BUD EXTRACT, PHENOXYETHNOL, PETASITES VULGARIS LEAF EXTRACT, PEG-100 STEARATE, ISOPROPYL PALMITATE, HYDROXYPROPYL METHYL CELLULOSE, GLYCERYL STEARATE, GLYCERETH-2 COCOATE, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, ETHYLHEXYLGLYCERIN, CETEARYL ALCOHOL, CANNABIS SATIVA OIL, BOSWELLIA SERRATA GUM, BENZOIC ACID, ALOE BARBADENSIS LEAF JUICE, ACRYLATES/C10-30 ACRYLATE CROSSPOLYMER

OTHER INFORMATION

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

QUESTIONS OR COMMENTS

(917) 745-3082

HEMP PAIN RELIEF 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80551-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SALIX ALBA BARK (UNII: 205MXS71H7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PINUS PINASTER SEED OIL (UNII: R3P3P606BY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PETASITES AMPLUS WHOLE (UNII: RRQ4T8055N)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL ALCOHOL (UNII: 936JST6JCN)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80551-101-04	113 g in 1 TUBE; 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: 14ac1dcc-463c-d07f-e063-6394a90aaa23

34390-5

Set id: e6a441ec-0c09-46b3-8c32-7d4601ee5769

Version: 5

Effective Time: 20240327