Search by Drug Name or NDC

NDC 72614-0266-03 CANNA NUMB Pain Relief 40; 10 mg/mL; mg/mL Details

CANNA NUMB Pain Relief 40; 10 mg/mL; mg/mL

CANNA NUMB Pain Relief is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by HEMPAGENIX, LLC. The primary component is LIDOCAINE HYDROCHLORIDE; MENTHOL.

Product Information

NDC	72614-0266
Product ID	72614-266_87acf31e-e613-6ecd-e053-2a95a90a90d1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CANNA NUMB Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE HYDROCHLORIDE, MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	40; 10
Active Ingredient Units	mg/mL; mg/mL
Substance Name	LIDOCAINE HYDROCHLORIDE; MENTHOL
Labeler Name	HEMPAGENIX, LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72614-0266-03 (72614026603)

Pricing Information	N/A
NDC Package Code	72614-266-03
Billing NDC	72614026603
Package	3 mL in 1 PACKET (72614-266-03)
Marketing Start Date	2019-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 88ed2e86-5098-44a4-844f-7ffe79bc1973 Details

Drug Facts

Active Ingredients

Lidocaine HC1 4%

Menthol 1%

Purpose

Topical Anesthetic

Use

temporarily relieves minor pain

Warnings

For external use only

Do Not Use

on large areas of the body or on cut, irritated or swollen skin
on puncture wounds
for more than one week without consulting a doctor

When using this product

use only as directed. Read and follow directions and warnings on this packet.
avoid contact with eyes and mucous membranes
rare cases of serious burns have been reported with products of this type
do not apply to wounds or damaged, broken or irritated skin
do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
a transient burning sensation may occur upon application but generally disappears in several days
avoid applying into skin folds

Stop use and ask a doctor if

conditions worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Flammable
keep away from fire or flame

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
massage into painful area until thoroughly absorbed into skin children 12 years or younger: ask a doctor

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil*, Carbomer, Citrus Aurantium Dulcis (Orange) Oil, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguayensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, Salix Nigra (Willow) Bark Extract, SD-Alcohol 40B, Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

CANNA NUMB PAIN RELIEF

lidocaine hydrochloride, menthol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72614-266
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ORANGE OIL (UNII: AKN3KSD11B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72614-266-03	3 mL in 1 PACKET; Type 0: Not a Combination Product	05/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2019

Labeler - HEMPAGENIX, LLC (081350922)

Revised: 4/2019

Document Id: 87acf31e-e613-6ecd-e053-2a95a90a90d1

Set id: 88ed2e86-5098-44a4-844f-7ffe79bc1973

Version: 1

Effective Time: 20190429