HERBAL

Main information

  • Trade name:
  • HERBAL UTAPLAS.TN menthol methyl salicylate patch
  • Composition:
  • MENTHOL 0.05 g in 1 g
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HERBAL UTAPLAS.TN menthol methyl salicylate patch
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Last update:
  • 16-01-2018

Summary of Product characteristics: dosage, interactions, side effects

HERBAL UTAPLAS.TN- menthol, methyl salicylate patch

Albert Max, Inc.

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.

----------

Drug Facts Active Ingredients

Menthol 5%

Methyl Salicylate 0.5%

Purpos es

External Analgesic

Keep out of reach of children

Keep out of reach of children to avoid accidental poisoning.

In case of overdose, get medical help or contact a Poison Control Center right away.

Us es

For the temporary relief of minor aches and pains of muscles and joints due to:

arthritis

strains

bruises

sprains

simple backaches

Warnings

For external use only

Do not use otherwise than as directed

Do not use

on wounds

irritated or damaged skin

sensitive skin

with a heating pad

if pregnant

with, or as the same time as other external analgesic products

if allergic to aspirin or salicylates

if allergic to any ingredients of this product

When using this product

avoid contact with the eyes

do not bandage tightly

do not apply to wounds or damaged skin

do not use more than 3 plasters a day

do not use 1 hour before or after bathing

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive irritation of the skin develops

rashes, itching or redness are present

side effects occur.

If pregnant,

ask a health professional before use.

Directions

Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the

protective layer, apply to the affected area, rub the area with your hand to secure the patch.

Plaster will remain effective for 8 hours.

Avoid using the same patch on the same area for more than 2 days.

Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.

Wet patch with warm water before removing from skin.

Children under 12 years of age: Do not use or consult a doctor.

Other Information

Store unused patch in the pouch

Store at room temperature, 20 to 25° C (68 to 77° F)

Inactive Ingredients

Sesame Oil, Resin, Zinc Oxide, Angelicae Dahuricae Root, angelicae Sinensis Root, Chinese

Cinnamon, Momordica Cochinchinensis Seed, Paeonia Veitchii Root, Rehmannia Glutinosa Root,

Rheum Officinale Root, Scrophularia Ningpoensis Root, Crinis Carbonisatus, Frankincense, Asafetida,

Myrrha, FD and C Yellow No. 5, FD and C Blue No. 2

Questions or Comments

Call: 1-888-811-1133

Product Label

NDC:

Herbal

UTAPLAS.TN

External Analgesic Plaster

America Herbs T and N Incorporated

Backache

Arthritis

Strains

Bruises

Sprains

Elastic Breathable Pad

FOR EXTERNAL USE ONLY

Contains 10 Plasters 7.5X10cm(2.9 inch X 3.9 inch)

CUT HERE

RESEAL POUCH AFTER OPENING

For the temporary relief of muscles and joints associated with arthritis.

Distributer by:

T.N. America Herbs Inc.

P.O. Box 18286

Anaheim, CA 92817

Tel 1-888-811-1133 or 714-720-4092

Fax 714-692-4092

www.tnamericaherba.com

www.duocthaoth.com

USA and Taiwan Cooperative

Made in Taiwan

896586000172

HERBAL UTAPLAS.TN

menthol, methyl salicylate patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 233-0 12

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .0 5 g in 1 g

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

0 .0 0 5 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SESAME O IL (UNII: QX10 HYY4QV)

PINUS MASSO NIANA RESIN (UNII: 6 4S0 7U8 3T7)

ZINC O XIDE (UNII: SOI2LOH54Z)

ANGELICA DAHURICA RO O T (UNII: 1V6 3N2S9 72)

ANGELICA SINENSIS RO O T (UNII: B6 6 F4574UG)

CHINESE CINNAMO N (UNII: WS4CQ0 6 2KM)

MO MO RDICA CO CHINCHINENSIS SEED (UNII: 2T8 7O1UPVD)

PAEO NIA VEITCHII RO O T (UNII: VX6 GD6 M9 3V)

REHMANNIA GLUTINO SA RO O T (UNII: 1BEM3U6 LQQ)

RHEUM O FFICINALE RO O T (UNII: A47JP5ZG9 M)

SCRO PHULARIA NINGPO ENSIS RO O T (UNII: HC0 FB6 P8 5R)

HUMAN HAIR (UNII: 1AWP0 DKL4I)

FRANKINCENSE (UNII: R9 XLF1R1WM)

ASAFETIDA (UNII: W9 FZA51AS1)

MYRRH (UNII: JC71GJ1F3L)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 233-0 12-0 1

10 in 1 POUCH

12/0 1/20 0 4

0 3/31/20 18

1

1.76 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

12/0 1/20 0 4

0 3/31/20 18

Albert Max, Inc.

Labeler -

Albert Max, Inc. (149445798)

Registrant -

Albert Max, Inc. (149445798)

Revised: 10/2017