DIOLPURE LIDOCAINE PAIN RELIEF CREAM- lidocaine hcl 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 DiolPure, LLC, BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

DIOLPURE LIDOCAINE PAIN RELIEF CREAM 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82093-002
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: 82093-002-01	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(82093-002)