PURE PERSONAL ALL NATURAL PAIN RELIEF CREAM- menthol cream

PURE PERSONAL All Natural Pain Relief Cream by

Drug Labeling and Warnings

PURE PERSONAL All Natural Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by PURE PERSONAL CARE, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - PURE PERSONAL CARE, LLC (085296835)