Label: SOMEASE- melatonin spray, metered
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Contains inactivated NDC Code(s)
NDC Code(s): 71902-100-01, 71902-100-02 - Packager: Biotico Health Canada Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 1, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients:
- PURPOSE
- INDICATIONS & USAGE
- Warnings:
- KEEP OUT OF REACH OF CHILDREN
- Usage Instructions:
- Inactive Ingredients:
- Storage Instructions:
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SPL UNCLASSIFIED SECTION
Melatonin Oral Spray
For Busy People
For people with insomnia
For people with sleeplessness due to stress
Sleep faster, sleep better. 4 times stronger and 3 times faster than other sleep products.*
Developed in Italy, Somease is the natural solution for difficult sleeping. Somease is a sublingual food spray containing melatonin that reduces the time it takes to fall asleep and helps you wake up without morning sleepiness and discomfort. Somease’s patented nano emulsion allows for rapid absorption (5 minutes) by the body.
*compared to sleep products in capsule form containing melatonin.
Non-GMO
Gluten Free
Nut Free
Somease,Toronto, Ontario, Canada
www.somease.com
Made in Italy
Biotico Health Canada Limited Toronto, Ontario M9W 6V6 CANADA
Email us at: hello@bioti.co
- Packaging
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INGREDIENTS AND APPEARANCE
SOMEASE
melatonin spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71902-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN 1 mg in 0.2 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ASCORBYL PALMITATE (UNII: QN83US2B0N) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71902-100-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2018 2 NDC:71902-100-02 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/15/2018 Labeler - Biotico Health Canada Limited (203529276)
