DiolPure Lidocaine Pain Relief Cream

DiolPure Lidocaine Pain Relief Cream by

Drug Labeling and Warnings

DiolPure Lidocaine 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 LIDOCAINE PAIN RELIEF CREAM- lidocaine hcl 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 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

• Adults and children 12 years of age and older: Apply to affected area every 6 to 8 hours, do not exceed 3 to 4 applications in a 24 hour period
• Before and after applying, wash hands with soap and water
• Children under 12 years of age: Consult a doctor

Other information

• store in a cool, dry place
• avoid direct sunlight

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)

DIOLPURE LIDOCAINE PAIN RELIEF CREAM 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73439-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73439-701-01	1 in 1 CARTON	07/01/2021	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	07/01/2021

Labeler - PureForm Global (081350045)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories, LLC		015560564	manufacture(73439-701)

Revised: 7/2021

Document Id: c6a8fe27-3703-1cc0-e053-2995a90af71a

34390-5

Set id: c6148367-8bd5-7372-e053-2a95a90a27fc

Version: 2

Effective Time: 20210708