DIOLPURE MENTHOL PAIN RELIEF CREAM- menthol, camphor cream

DiolPure Menthol Pain Relief Cream by

Drug Labeling and Warnings

DiolPure Menthol Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by DiolPure, LLC, BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol USP 12%

Camphor 6%

Purpose

Menthol USP 12%.....................Topical Analgesic

Camphor 6%.............................Topical Analgesic

Uses

for temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises

Warnings

For external use only

Do not use

• on damaged or broken skin

When using this product

• do not bandage tightly
• avoid contact with eyes

Stop use and ask doctor if

• condition worses or persists
• rash develops

If pregnant or breastfeeding consult your doctor before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily
• Children under 12 years of age: Consult a doctor

Other information

• Store in a cool, dry place
• Avoid direct sunlight

Inactive ingredients

Arnica Montana, Calendula Officinalis, Cannabidiol, Carbomer, Citric Acid, Ethyl Alcohol, Methyl Glucose Dioleate, Methylsulfonylmethane (MSM), Organic Medium-Chain Triglyceride (MCT), Coconut Oil, Purified Water, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

DiolPure

Menthol 12%

Pain Relief Cream

500MG CBD to moisturize skin

Menthol 12%

For temporary relief of minor aches and pains

Net Wt. 2 oz (56.7 g)

INGREDIENTS AND APPEARANCE

DIOLPURE MENTHOL PAIN RELIEF CREAM 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82093-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	6 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALCOHOL (UNII: 3K9958V90M)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ARNICA MONTANA (UNII: O80TY208ZW)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82093-001-01	1 in 1 CARTON	07/01/2021
1		56.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2021

Labeler - DiolPure, LLC (118147963)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories, LLC		015560564	manufacture(82093-001)