MELATONIN- melatonin, liquid
Apotheca Company

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.

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Melatonin

ACTIVE INGREDIENTS: Melatonin 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C.

INDICATIONS: For temporary relief of symptoms related to sleep disorders, Seasonal Affective Disorder, jet lag, and depression.

WARNINGS: Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

DIRECTIONS: 1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, contact physician or Poison Control Center right away.

INDICATIONS: For temporary relief of symptoms related to sleep disorders, Seasonal Affective Disorder, jet lag, and depression.

Dist. By:

Deseret Biologicals, Inc.

469 Parkland Drive

Sandy, UT 84070

www.desbio.com

DESBIO

NDC 57520-0729-1

HOMEOPATHIC

MELATONIN

1 FL OZ (30 ML)

Melatonin

MELATONIN
melatonin, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0729
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	200 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0729-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/15/2011	11/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/15/2011	11/30/2022

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0729) , api manufacture(57520-0729) , label(57520-0729) , pack(57520-0729)

Revised: 11/2022

Document Id: 4c03b654-663c-47db-b893-86430f4f0e6b

Set id: fdaf86c2-137d-4926-a63b-9faf7ec7e04c

Version: 2

Effective Time: 20221115

Apotheca Company