Canna Numb Roll-on

Canna Numb Roll-on
SPL v4
SPL
SPL Set ID c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4
Route
TOPICAL
Published
Effective Date 2018-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Water Arnica Montana Cannabis Sativa Seed Oil Carboxypolymethylene Orange Oil Ethylhexylglycerin Glucosamine Sulfate Ilex Paraguariensis Leaf Magnesium Sulfate, Unspecified Form Dimethyl Sulfone Phenoxyethanol Polysorbate 20 Propylene Glycol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-01

Description

Lidocaine HCl 4% Menthol 1%

Purpose

Topical Anesthetic Topical Analgesic


Medication Information

Purpose

Topical Anesthetic

Topical Analgesic

Description

Lidocaine HCl 4% Menthol 1%

Uses:
  • 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
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 
  •  ask a doctor children 12 years or younger:
Package Labeling:

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

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, Methylsulfonylemthane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, Salix Nigra (Willow) Bark Extract, Sd-Alcohol 40B, Triethanolamine.

When Using This Product
  • use only as directed. Read and follow directions and warnings on this package.
  • 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
  • redeness 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
  • - keep away from fire or flame Flammable
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.


Structured Label Content

Uses:
  • temporarily relieves minor pain
Purpose

Topical Anesthetic

Topical Analgesic

Warnings:

For external use only.

Do Not Use (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
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 
  •  ask a doctor children 12 years or younger:
Package Labeling:

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

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, Methylsulfonylemthane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, Salix Nigra (Willow) Bark Extract, Sd-Alcohol 40B, Triethanolamine.

When Using This Product (When using this product)
  • use only as directed. Read and follow directions and warnings on this package.
  • 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 (Stop use and ask a doctor if)
  • conditions worsens
  • redeness 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
  • - keep away from fire or flame Flammable
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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


Advanced Ingredient Data


Raw Label Data

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