PENETREX(R) ARTHRITIS PAIN RELIEF- capsaicin cream

Penetrex(r) Arthritis Pain Relief by

Drug Labeling and Warnings

Penetrex(r) Arthritis Pain Relief by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Capsaicin 0.025%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses

Temporarily relieves minor pains of muscles and joints associated with arthritis,simple backache,muscle strains,bruises,sprains,cramps

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

on wounds, damaged, or irritated skin

with a heating pad

if you are alergic to capsicum or chili peppers

WHEN USING

When using this product

Read directions befbre using

use only as directed; read and follow all directions and warnings on this carton rare cases of serious bums have been reported with products of this type

do not bandage tightly or apply local heat (such as heating pads) to the area of use

avoid contact with eyes and mucous membranes

do not apply to wounds or damaged, broken or irritated skin

a transient burning sensation may occur upon application but generally disappears in several days

if severe burning occurs, discontinue use immediately

do not expose the area treated With product to heat or direct sunlight

do not use at the same time as other topical analgesics,

STOP USE

Stop use and ask a doctor if

condition worsens

redness is present

irritation develops

symptoms persist for more than 7 days or clear up and occur again within a few days

you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swalowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 18 years of age and older:

apply to affected area but no more than 3 to 4 times daily

massage onto painful area until thoroughly absorbed

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children under 18 years of age: ask a doctor

OTHER SAFETY INFORMATION

If pregnant or breast-feeding, ask a health professional before use

INACTIVE INGREDIENT

Inactive ingredients:

Water (Aqua),Helanthus Annuus (Sunflower) Seed Oil, Glycerin,GlycerylStearates, Amica Montana Flower Extract,

Cetearyl Alcohol,Ceteareth-20,PEG-100 Stearate, Butyrospermum Parkii (Shea) Buffer,Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer, Aloe Barbadensis Leaf Juice,Dimethicone, Ethoxydiglycol, Phenoxyethanol,

Methyl Gluceth-20,Menthe Piperita Oil,Camphor,Ethylhexylglycerin,Potassium Sorbate, Glucosamine HCI,Choline Bitartrate,

Pyridoxine HCL, Glycyrrhizinate Dipotassium, Methyl sulfonyl Methane,Disodium EDTA, Boswellia carterii oil,

Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol, Citric Acid,Beta-Sitosterol, Squalene.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PENETREX(R) ARTHRITIS PAIN RELIEF 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
SHEA BUTTER (UNII: K49155WL9Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
DIMETHICONE (UNII: 92RU3N3Y1O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
SQUALENE (UNII: 7QWM220FJH)
CETYL ESTERS WAX (UNII: D072FFP9GU)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4216-2	1 in 1 CARTON	06/20/2022
1	NDC: 62742-4216-1	57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/20/2022

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4216)