OTC Medication Information: HEMP PAIN RELIEF

HEMP PAIN RELIEF- menthol gel
ACUTENS, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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HEMP PAIN RELIEF
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80551-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
ARNICA MONTANA FLOWER
PROPYLENE GLYCOL
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
AMINOMETHYL PROPANEDIOL
ALOE VERA LEAF
PYRIDOXINE HYDROCHLORIDE
DIMETHYL SULFONE
CANNABIS SATIVA SEED OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80551-102-04 113 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/20/2021
Labeler — ACUTENS, INC. (051133165)

Revised: 01/2023 ACUTENS, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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