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NDC 82093-0002-01 DiolPure Lidocaine Pain Relief Cream 4 g/100g Details

DiolPure Lidocaine Pain Relief Cream 4 g/100g

DiolPure Lidocaine Pain Relief Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by DiolPure, LLC. The primary component is LIDOCAINE.

Product Information

NDC	82093-0002
Product ID	82093-002_c6b3df6f-f18d-7a5f-e053-2995a90a96b4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DiolPure Lidocaine Pain Relief Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine HCL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE
Labeler Name	DiolPure, LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 82093-0002-01 (82093000201)

Pricing Information	N/A
NDC Package Code	82093-002-01
Billing NDC	82093000201
Package	1 BOTTLE, PUMP in 1 CARTON (82093-002-01) / 56.7 g in 1 BOTTLE, PUMP
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c6b3df6f-f18e-7a5f-e053-2995a90a96b4 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/01/2021

Labeler - DiolPure, LLC (118147963)

Name	Address	ID/FEI	Business Operations
Establishment
BioLyte Laboratories, LLC		015560564	manufacture(82093-002)

Revised: 7/2021

Document Id: c6b3df6f-f18d-7a5f-e053-2995a90a96b4

Set id: c6b3df6f-f18e-7a5f-e053-2995a90a96b4

Version: 1

Effective Time: 20210709