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NDC 82093-0001-01 DiolPure Menthol Pain Relief Cream 6; 12 g/100g; g/100g Details

DiolPure Menthol Pain Relief Cream 6; 12 g/100g; g/100g

DiolPure Menthol 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 CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	82093-0001
Product ID	82093-001_c6b3d3e9-ded9-16ff-e053-2a95a90ad972
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 Menthol Pain Relief Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol, Camphor
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	6; 12
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL
Labeler Name	DiolPure, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 82093-0001-01 (82093000101)

Pricing Information	N/A
NDC Package Code	82093-001-01
Billing NDC	82093000101
Package	1 BOTTLE, PUMP in 1 CARTON (82093-001-01) / 56.7 g in 1 BOTTLE, PUMP
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c6b3d442-9943-5e01-e053-2995a90a4513 Details

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

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

DIOLPURE MENTHOL PAIN RELIEF CREAM

menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82093-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	6 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82093-001-01	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(82093-001)

Revised: 7/2021

Document Id: c6b3d3e9-ded9-16ff-e053-2a95a90ad972

Set id: c6b3d442-9943-5e01-e053-2995a90a4513

Version: 1

Effective Time: 20210709