Label: MYRRH WOMAN ESSENCE- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 72263-0001-1 - Packager: MIR BIOTECHNOLOGY
- 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 April 26, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight2. Do not use on open wounds, eczema, and other irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight4. Use as avoiding eye areas.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MYRRH WOMAN ESSENCE
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72263-0001 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MENTHOL (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72263-0001-1 20 g in 1 TUBE; Type 0: Not a Combination Product 04/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/27/2018 Labeler - MIR BIOTECHNOLOGY (694203851) Registrant - MIR BIOTECHNOLOGY (694203851) Establishment Name Address ID/FEI Business Operations MIR BIOTECHNOLOGY 694203851 manufacture(72263-0001)