MOMR Rumaian Herbal Bandage: Package Insert and Label Information

MOMR RUMAIAN HERBAL BANDAGE- levomenthol and 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.

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
(click image for full-size original)

MOMR RUMAIAN HERBAL BANDAGE
l-menthol, methyl salicylate patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69559-3921
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 0.09 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.3 g
Inactive Ingredients
Ingredient Name Strength
COTTON FIBER
OLDENLANDIA DIFFUSA
ANGELICA SINENSIS WHOLE
REHMANNIA GLUTINOSA WHOLE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69559-3921-3 2 PATCH in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/23/2014
Labeler — MARYHELEN ORIENTAL MEDICINE RESEARCH (079650440)
Establishment
Name Address ID/FEI Operations
MARYHELEN ORIENTAL MEDICINE RESEARCH 079650440 manufacture (69559-3921)

Revised: 02/2015 MARYHELEN ORIENTAL MEDICINE RESEARCH

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