DR TANS ARTHRITIS FORMULA 3 DAY PATCH- menthol patch
Great Loong LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dr Tans Arthritis Formula 3 day Patch

Actives

Menthol 0.5 %

Inactives

Borneol , Carthamus Tinctorious L. , Draconis Sanguis, Frankincense, Ligusticum Walichii, Padix Auklandiae, Radix Angelicae Forrnosanae, Radix Paeoniae Rubra, Rheum Officinale Baillon, Sandalwood, Syzygium Aromaticum, hydrogel.

Purpose

External Analgesic

Indication and Usage

For adults and children 10 and older for the temporary relief of: • chronic arthritis • backache • joint and muscle pain and stiffness • old sports injuries.

Directions

Clean and dry the affected area. Peel film off of patch and apply the herbal-formula side onto the skin. Peel film off the larger dressing patch and apply over the herbal patch to secure it in place. Patch will continue to release herbal formula to the skin for 3 days if desired.

Warnings

• For external use only. • Do not apply to open sores or wounds. • If skin irritation or a rash occurs, remove patch and consult physician. ·Avoid contact with eyes and mucous membranes. • If pregnant or breast feeding, consult a doctor before using.

Keep out of reach of children

Product label

artrhritis

DR TANS ARTHRITIS FORMULA 3 DAY PATCH
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71446-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
BORNEOL (UNII: M89NIB437X)
CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)
DRAGON'S BLOOD (UNII: M3YJ2C28IC)
FRANKINCENSE (UNII: R9XLF1R1WM)
LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)
ANGELICA DAHURICA VAR. FORMOSANA ROOT (UNII: 924AE5NXTL)
PAEONIA ANOMALA ROOT (UNII: 6Z79LE5470)
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)
SANDALWOOD (UNII: 3641YW25N2)
SYZYGIUM AROMATICUM LEAF (UNII: 4884JIE1TX)
GLYCERIN (UNII: PDC6A3C0OX)
CROSPOVIDONE (UNII: 2S7830E561)
POVIDONE K90 (UNII: RDH86HJV5Z)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71446-001-01	2 in 1 PACKAGE	05/23/2017
1		0.5 g in 1 PATCH; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/23/2017

Labeler - Great Loong LLC (041552971)

Name	Address	ID/FEI	Business Operations
Establishment
Tianjin Ruide Pharmaceutical Co., Ltd.		547738337	manufacture(71446-001)