MOMR RUMAIAN HERBAL BANDAGE- l-menthol, methyl salicylate patch 
MARYHELEN ORIENTAL MEDICINE RESEARCH

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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MOMR Rumaian Herbal Bandage

Active ingredients: (each patch contains 3 grams)

L-MENTHOL – 3.0%
Methyl Salicylate – 10%

PURPOSE

EXTERNAL ANALGESIC

Keep out reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

USES for the relief of pain in breasts.

WARNINGS – For external use only.

Do not use:
• On wounds
• On infected or damaged skin
• While exercising or performing sweaty activities (yoga, swimming, and etc.,)

When using this product:
• Avoid contact with eyes or mouth
• Do not bandage tightly

Stop use and ask a doctor if:
• Condition worsens
• Symptom clear up and occur again within a few days.
• Symptom persist for more than 7 days.
• Nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs.
• Excessive irritation of the skin develops

Direction:

• For adult women use only
• Take Rumaian patches out of the box and place on the side of each of the breasts.

Directionimage

• Use once a day, leave both patches on for 3-6 hours
• Remove patches after usage and place back in the box
• Patches are effective for 30 days

Other information:

• When storing, keep patches away from sun exposure

Inactive ingredients: Cotton, Oldenlandia Diffusa, Angelica sinensis and Rehmannia glutinosa.

Packaging

MOMR Herbal

MOMR RUMAIAN HERBAL BANDAGE 
l-menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69559-3921
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL0.09 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.3 g
Inactive Ingredients
Ingredient NameStrength
COTTON FIBER (UNII: 70LDW53ROO)  
OLDENLANDIA DIFFUSA (UNII: 291PPU5K9I)  
ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
REHMANNIA GLUTINOSA WHOLE (UNII: 37S3F886KQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69559-3921-32 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2014
Labeler - MARYHELEN ORIENTAL MEDICINE RESEARCH (079650440)
Establishment
NameAddressID/FEIBusiness Operations
MARYHELEN ORIENTAL MEDICINE RESEARCH079650440manufacture(69559-3921)

Revised: 2/2015
Document Id: 19e6f005-58b1-416b-a6ab-7e0340cb9e20
Set id: 4a9ea13a-87a7-41aa-9000-49c56e7c0363
Version: 2
Effective Time: 20150201
 
MARYHELEN ORIENTAL MEDICINE RESEARCH