Drug Facts

Active Ingredients

Menthol 3.00 %

Purpose

Topical Analgesic

Uses:

Temporary relief of minor aches and pains of muscles and joints, associated with • arthritis simple backache • strains • bruises • sprains.

Warning:

For external use only

Do not use:

On damaged or broken skin

When using this product

Avoid contact with the eyes.
Do not bandage tightly.

Stop use and ask a doctor if

Rash or irritation develops and lasts
Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

IF PREGNANT OR BREAST FEEDING

ask a health professional before use

Directions:

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.

Other information:

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Carterii (Frankincense) Oil, Cannabis Saliva (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Cinnamomum Cassia Leaf Oil, Curcuma Longa (Turmeric) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Magnesium Sulfate, Olea Europaea (Olive) Oil, Phenoxyethanol, Piper Nigrum (Black Pepper) Extract, Polysorbate-20, Propylene Glycol, Triethanolamine

954-747-1221

Package Labeling:

Label

HAV EZ PENETRATING PAIN RELIEF
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:84093-442
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
FRANKINCENSE (UNII: R9XLF1R1WM)
HEMP (UNII: TD1MUT01Q7)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)
TURMERIC (UNII: 856YO1Z64F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GREEN OLIVE (UNII: 6HD2W46UEG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BLACK PEPPER (UNII: KM66971LVF)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:84093-442-00	60 mL in 1 JAR; Type 0: Not a Combination Product	01/02/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/02/2024

Labeler - PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC (013747732)

HAV EZ Penetrating Pain Relief Gel