DIOLPURE LIDOCAINE PAIN RELIEF CREAM- lidocaine hcl cream 
DiolPure, LLC

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 Lidocaine Pain Relief Cream

Active ingredient

Lidocaine HCL 4%

Purpose

Lidocaine HCL 4%.................Topical Anesthetic

Uses

for temporary relief of minor joint and muscle pain

Warnings

For external use only

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask doctor if

  • condition worsens
  • symptoms persist for more than 7 days

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

Other information

Inactive ingredients

Aloe Barbadensis Leaf Extract, Cannabidiol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ethylhexylglycerin, Methyl Glucose Dioleate, Organic Medium-Chain Triglyceride (MCT), Coconut Oil, Purified Water, Sodium Hydroxide

DiolPure

Lidocaine 4%

Pain Relief Cream

Uscented

500MG CBD to moisturize skin

Lidocaine 4%

For temporary relief of minor joint and muscle pain

Net Wt. 2 oz (56.7 g)

1

2

DIOLPURE LIDOCAINE PAIN RELIEF CREAM 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82093-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82093-002-011 in 1 CARTON07/01/2021
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 finalpart34807/01/2021
Labeler - DiolPure, LLC (118147963)
Establishment
NameAddressID/FEIBusiness Operations
BioLyte Laboratories, LLC015560564manufacture(82093-002)

Revised: 7/2021
Document Id: c6b3df6f-f18d-7a5f-e053-2995a90a96b4
Set id: c6b3df6f-f18e-7a5f-e053-2995a90a96b4
Version: 1
Effective Time: 20210709
 
DiolPure, LLC