Drug Facts

Active Ingredients

Menthol 7.5 %

Purpose

Topical Analgesic

Uses:

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

Warnings:

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:

Aqua (Deionized Water), Beeswax, Boswellia Carterii (Frankincense) Oil, Camphor, Cannabis Sativa (Hemp) Seed Oil, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Globulus Oil, Eugenia Caryophyllus (Clove) Bud Oil, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isopropyl Alcohol, Mangifera Indica (Mango) Butter, Mentha Piperita (Peppermint) Oil, Methyl Salicylate, Tocopherol (Vitamin E), Xanthan Gum.

Questions or comments?

419-461-9916

Package Labeling:

Label2

PURE PERSONAL ALL NATURAL PAIN RELIEF CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83072-374
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CLOVE OIL (UNII: 578389D6D0)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MANGO (UNII: I629I3NR86)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83072-374-00	59 mL in 1 JAR; Type 0: Not a Combination Product	10/24/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/24/2022

Labeler - PURE PERSONAL CARE, LLC (085296835)

PURE PERSONAL All Natural Pain Relief Cream