SPL v1
SPL
SPL Set ID 361c19ab-a7ad-4bce-a8aa-1f4dbfd28e76
Route
TOPICAL
Published
Effective Date 2023-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (4 g)
Inactive Ingredients
Water Olive Oil Shea Butter Mango Cannabis Sativa Seed Oil .alpha.-tocopherol Cetostearyl Alcohol Palmarosa Oil Tea Tree Oil Eucalyptus Oil Camphor (natural) Lavender Oil Ginger Oil Capsicum Oleoresin Aloe Vera Leaf Phenoxyethanol Arnica Montana Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-05-07

Description

Active Ingredients                Purpose Lidocaine HCl 4%                  Topical Anesthetic Menthol 1%                          Topical Analgesic


Medication Information

Description

Active Ingredients                Purpose Lidocaine HCl 4%                  Topical Anesthetic Menthol 1%                          Topical Analgesic

Uses

Fast Pain Relief

Section 50565-1

Section 55105-1

Section 55106-9

Active Ingredients                Purpose

Lidocaine HCl 4%                  Topical Anesthetic

Menthol 1%                          Topical Analgesic

Warnings

FOR EXTERNAL USE ONLY. NOT INTENDED FOR INGESTION DONT USE ONLARGE AREAS OF THE BODY OR ON CUT, IRRITATED OR SWOLLEN SKIN. Use only as directed, avoid contact with eyes and mucus membranes If pregnant or breast-feeding, ask a health care professional before use. If swallowed, get medical help

Direction

Apply topically to area. 

Product Label

Other Information

Great for : Sore muscles, aching joints, gout flare-ups and body pain and other sports related pain.

Menthol crystals gives instant cooling and pain releif. Physician formulated (roll-on-blend) glides on is non-sticky, and absorbs quickly.

Arnica reduces bruising and swelling. Lidocaine helps alleviate stiffness, inflammation, joint pain, muscle soreness and more. Hemp seed oil

allows ingredients to cross and absorb into the skin. With its healing properties, Emu oil reduces fibrosis from skin damage caused by radiation

therapy.

Inactive Ingredients

Purified water, Arnica, EMU OIL, MCT OIL, Hemp seed oil, Glyceryl stearate, Cetearyl Alcohol, Copaiba, Tea Tree, Basil, Rosemary, Rose, Lavender, Ginger, Capsicum, Bergamot


Structured Label Content

Uses

Fast Pain Relief

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Active Ingredients                Purpose

Lidocaine HCl 4%                  Topical Anesthetic

Menthol 1%                          Topical Analgesic

Warnings

FOR EXTERNAL USE ONLY. NOT INTENDED FOR INGESTION DONT USE ONLARGE AREAS OF THE BODY OR ON CUT, IRRITATED OR SWOLLEN SKIN. Use only as directed, avoid contact with eyes and mucus membranes If pregnant or breast-feeding, ask a health care professional before use. If swallowed, get medical help

Direction

Apply topically to area. 

Product Label (Product label)

Other Information (Other information)

Great for : Sore muscles, aching joints, gout flare-ups and body pain and other sports related pain.

Menthol crystals gives instant cooling and pain releif. Physician formulated (roll-on-blend) glides on is non-sticky, and absorbs quickly.

Arnica reduces bruising and swelling. Lidocaine helps alleviate stiffness, inflammation, joint pain, muscle soreness and more. Hemp seed oil

allows ingredients to cross and absorb into the skin. With its healing properties, Emu oil reduces fibrosis from skin damage caused by radiation

therapy.

Inactive Ingredients (Inactive ingredients)

Purified water, Arnica, EMU OIL, MCT OIL, Hemp seed oil, Glyceryl stearate, Cetearyl Alcohol, Copaiba, Tea Tree, Basil, Rosemary, Rose, Lavender, Ginger, Capsicum, Bergamot


Advanced Ingredient Data


Raw Label Data

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