DR JOE LAB ARTHRITIS EXTRA STRENGTH- trolamine salicylate cream

Dr Joe lab ARTHRITIS EXTRA STRENGTH by

Drug Labeling and Warnings

Dr Joe lab ARTHRITIS EXTRA STRENGTH by is a Otc medication manufactured, distributed, or labeled by DR JOE LAB, Despina Pharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Trolamine salicylate 10%.........................Topical Analgesic

uses

For the temporary relief of minor aches and pain
associated with simple strains, backaches, arthritis,
bruises, and sprains.

WARNINGS

Warnings
FOR EXTERNAL USE ONLY

Allergy Alert
If prone to allergic reaction from aspirin or salicylates,
consult a doctor before use

When Using

Use only as directed, do not bandage tightly or use with a heating pad.
Avoid contact with eyes or mucous membranes.
Do not apply to wounds or damaged, broken or irritated skin.
Do not use at the same time as other topical analgesics product.

Stop use and ask a doctor if

Condition worsens - Symptoms persist for more than 7
days or clear up and occur again within a few days -
Redness is present - Irritation develops

PREGNANCY OR BREAST FEEDING

If Pregnant or breast-feeding
Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right away

INSTRUCTIONS FOR USE

Apply generously to affected area.

Massage into painful area until thoroughly absorbed into skin.

Repeat as necessary, but no more than 3 to 4 times daily.

INACTIVE INGREDIENT

Water, Disodium EDTA, Aloe vera, Arnica Montana Flower Extract, Sodium Polyacrylate, Xanthan gum, Calendula Flower Extract, D-Glucosamine HCl, Willow Bark Extract, glycerin, Citric acid, Hydrogenated Polydecene, Propylene glycol, Hexylene Glycol, Sorbic acid, Caprylyl Glycol, Phenoxyethanol, Sodium hyaluronate, Trideceth-6, Dl-Panthenol, Acrylates/Palmeth- 25 Acrylates Copolymer, Vitamin E Acetate, Jojoba Oil, Red Raaspberry seed oil, Butylated hydroxytoluene, Black seed oil, Pomegranate seed oil, Emu oil, Sweet Almond oil.

QUESTIONS

Questions or Comments?
1-855-349-7735 or visit www.drjoelab.com to report serious
adverse events associated with use of the product.

DESCRIPTION

10% Trolamine Salicylate
EXTRA STRENGTH
FAST ACTING
UNSCENTED

CRAMP CALM

PURPOSE

Topical Analgesic

DOSAGE & ADMINISTRATION

Topical Cream,

Repeat as necessary, but no more than 3 to 4 times daily.

label

INGREDIENTS AND APPEARANCE

DR JOE LAB ARTHRITIS EXTRA STRENGTH 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82557-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
GLYCERIN (UNII: PDC6A3C0OX)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
SORBIC ACID (UNII: X045WJ989B)
ARNICA MONTANA (UNII: O80TY208ZW)
WILLOW BARK (UNII: S883J9JDYX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PANTHENOL (UNII: WV9CM0O67Z)
JOJOBA OIL (UNII: 724GKU717M)
RASPBERRY SEED OIL (UNII: 9S8867952A)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
EMU OIL (UNII: 344821WD61)
ALMOND OIL (UNII: 66YXD4DKO9)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82557-501-01	113 g in 1 JAR; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	06/01/2022

Labeler - DR JOE LAB (122311139)

Establishment
Name	Address	ID/FEI	Business Operations
Despina Pharma Inc		112281681	manufacture(82557-501)