DiolPure Menthol Pain Relief 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 PureForm Global, BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIOLPURE MENTHOL PAIN RELIEF CREAM- menthol, camphor cream 
PureForm Global

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DiolPure Menthol Pain Relief Cream

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

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)

1

2

DIOLPURE MENTHOL PAIN RELIEF CREAM 
menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73439-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73439-700-011 in 1 CARTON07/01/202107/01/2021
156.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/202107/01/2021
Labeler - PureForm Global (081350045)
Establishment
NameAddressID/FEIBusiness Operations
BioLyte Laboratories, LLC015560564manufacture(73439-700)

Revised: 7/2021
 

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