DR TANS PAIN RELEIVING 3 DAY HERABL PATCH- peppermint 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 Tan's Pain-Releiving 3 day Patch

Actives

PEPPERMINT 0.3 %

Inactives

Angelica Dahurica, Angelica Pubescens Maxim. f. , Carthamus Tinctorius, Draconis Sanguis, Drynaria Rhizome, Ligusticum Wallichii, Notopterygium lncisum, Phellodendron Amurense, Radix Angelicae Formosanae, Radix Angelicae Pubescentis, Rhizoma Corydalis, 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

pain-relief

DR TANS PAIN RELEIVING 3 DAY HERABL PATCH
peppermint patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71446-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	0.3 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)
CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)
DRAGON'S BLOOD (UNII: M3YJ2C28IC)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
ANGELICA DAHURICA VAR. FORMOSANA ROOT (UNII: 924AE5NXTL)
DICENTRA CANADENSIS ROOT (UNII: Y5JS7YM46F)
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:71446-002-01	2 in 1 PACKAGE	05/25/2017
1		0.3 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	part356	05/25/2017

Labeler - Great Loong LLC (041552971)

Name	Address	ID/FEI	Business Operations
Establishment
Tianjin Ruide Pharmaceutical Co., Ltd.		547738337	manufacture(71446-002)