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.

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Drug Facts Active Ingredients

Menthol 5%

Methyl Salicylate 0.5%

Purposes

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.

Uses

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

AlbertMax HerbalUtaplas Label

HERBAL UTAPLAS.TN 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68233-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)  
SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)  
HUMAN HAIR (UNII: 1AWP0DKL4I)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
ASAFETIDA (UNII: W9FZA51AS1)  
MYRRH (UNII: JC71GJ1F3L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68233-012-0110 in 1 POUCH12/01/200403/31/2018
11.76 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/200403/31/2018
Labeler - Albert Max, Inc. (149445798)
Registrant - Albert Max, Inc. (149445798)

Revised: 10/2017
 
Albert Max, Inc.