Label: MOMR RUMAIAN HERBAL BANDAGE- l-menthol, methyl salicylate patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated February 1, 2015

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  • Active ingredients: (each patch contains 3 grams)

    L-MENTHOL – 3.0%
    Methyl Salicylate – 10%

  • PURPOSE

    EXTERNAL ANALGESIC

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    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 INGREDIENT

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

  • Packaging

    MOMR Herbal

  • INGREDIENTS AND APPEARANCE
    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)
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