| NDC | 53405-0005-1 |
| Set ID | 5d9f2b09-bcd0-4d1a-91c4-90c3e0abe6dc |
| Category | HUMAN OTC DRUG LABEL |
| Packager | InLight Creation, LLC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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ACTIVE INGREDIENTS:
Rosa Canina 3X, Flos, Stillingia Sylvatica 3X, Zincum Gluconicum 3X, Thiaminum Hydrochloricum 4X, Fragaria Vesca 5X, Nicotinamidum 5X, Rheum (Officinale) 5X, Serotonin (Hydrochloride) 5X, 5-Hydroxytryptophan 6X, Betainum Muriaticum 6X, Biotin 6X, Cholinum 6X, Cysteinum 6X, DL-Methionine 6X, L-Alanine 6X, L-Cystine 6X, L-Glutamic Acid 6X, L-Glutamine 6X, L-Lysine 6X, L-Methionine 6X, L-Serine 6X, Oxytocin Acetate 6X, Para-Aminobenzoic Acid 6X, Potassium Gluconate 6X, Thymus (Suis) 6X, Thyroidinum (Suis) 6X, Ubidecarenonum 6X, Vitamin D3 6X, Dopamine Hydrochloride 7X, Lithium Bromatum 6X, Squalene 6X, Vaccinum Macrocarpon 7X, Cuprum Metallicum 8X, Phenylalanine 8X, Selenium Dioxide 8X, Selenium Metallicum 8X, Borrelia Burgdorferi Nosode 12X, Coconut Oil 12X, Candida Albicans 12X, 20X, 12C, 30C, Cucurbita Pepo, Semen 17X, Citrus Limonum 18X, Amaryllis Equestris 3C, Bromelain 6C, Aesculus Hippocastanum, Flos 30C, Ilex Aquifolium, Flos 30C, Malus Pumila, Flos 30C.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPALY:
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INGREDIENTS AND APPEARANCE
E.O.L.
rosa canina, flos, stillingia sylvatica, zincum gluconicum, thiaminum hydrochloricum, fragaria vesca, nicotinamidum, rheum (officinale), serotonin (hydrochloride), 5-hydroxytryptophan, betainum muriaticum, biotin, cholinum, cysteinum, dl-methionine, l-alanine, l-cystine, l-glutamic acid, l-glutamine, l-lysine, l-methionine, l-serine, oxytocin acetate, para-aminobenzoic acid, potassium gluconate, thymus (suis), thyroidinum (suis), ubidecarenonum, vitamin d3, dopamine hydrochloride, lithium bromatum, squalene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53405-0005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) (ROSA CANINA FLOWER - UNII:81MCR2UQ6Q) ROSA CANINA FLOWER 3 [hp_X] in 1 mL STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK) STILLINGIA SYLVATICA ROOT 3 [hp_X] in 1 mL ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 3 [hp_X] in 1 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 4 [hp_X] in 1 mL ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY 5 [hp_X] in 1 mL RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT 5 [hp_X] in 1 mL SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN HYDROCHLORIDE 5 [hp_X] in 1 mL OXITRIPTAN (UNII: C1LJO185Q9) (OXITRIPTAN - UNII:C1LJO185Q9) OXITRIPTAN 5 [hp_X] in 1 mL BETAINE HYDROCHLORIDE (UNII: JK8U8K4D6K) (BETAINE - UNII:3SCV180C9W) BETAINE HYDROCHLORIDE 6 [hp_X] in 1 mL BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 6 [hp_X] in 1 mL CHOLINE HYDROXIDE (UNII: 7THJ3EG9SY) (CHOLINE - UNII:N91BDP6H0X) CHOLINE HYDROXIDE 6 [hp_X] in 1 mL UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE 6 [hp_X] in 1 mL CYSTEINE (UNII: K848JZ4886) (CYSTEINE - UNII:K848JZ4886) CYSTEINE 6 [hp_X] in 1 mL RACEMETHIONINE (UNII: 73JWT2K6T3) (RACEMETHIONINE - UNII:73JWT2K6T3) RACEMETHIONINE 6 [hp_X] in 1 mL ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE 6 [hp_X] in 1 mL CYSTINE (UNII: 48TCX9A1VT) (CYSTINE - UNII:48TCX9A1VT) CYSTINE 6 [hp_X] in 1 mL GLUTAMIC ACID (UNII: 3KX376GY7L) (GLUTAMIC ACID - UNII:3KX376GY7L) GLUTAMIC ACID 6 [hp_X] in 1 mL GLUTAMINE (UNII: 0RH81L854J) (GLUTAMINE - UNII:0RH81L854J) GLUTAMINE 6 [hp_X] in 1 mL LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE 6 [hp_X] in 1 mL METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE 6 [hp_X] in 1 mL SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE 6 [hp_X] in 1 mL OXYTOCIN ACETATE (UNII: 4NR672T8NL) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN ACETATE 6 [hp_X] in 1 mL AMINOBENZOIC ACID (UNII: TL2TJE8QTX) (AMINOBENZOIC ACID - UNII:TL2TJE8QTX) AMINOBENZOIC ACID 6 [hp_X] in 1 mL POTASSIUM GLUCONATE (UNII: 12H3K5QKN9) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM GLUCONATE 6 [hp_X] in 1 mL SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS 6 [hp_X] in 1 mL SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID 6 [hp_X] in 1 mL CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 6 [hp_X] in 1 mL DOPAMINE HYDROCHLORIDE (UNII: 7L3E358N9L) (DOPAMINE - UNII:VTD58H1Z2X) DOPAMINE HYDROCHLORIDE 7 [hp_X] in 1 mL LITHIUM BROMIDE (UNII: 864G646I84) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM BROMIDE 7 [hp_X] in 1 mL SQUALENE (UNII: 7QWM220FJH) (SQUALENE - UNII:7QWM220FJH) SQUALENE 7 [hp_X] in 1 mL CRANBERRY (UNII: 0MVO31Q3QS) (CRANBERRY - UNII:0MVO31Q3QS) CRANBERRY 7 [hp_X] in 1 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 8 [hp_X] in 1 mL PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE 8 [hp_X] in 1 mL SELENIUM DIOXIDE (UNII: 9N3UK29E57) (SELENIUM DIOXIDE - UNII:9N3UK29E57) SELENIUM DIOXIDE 8 [hp_X] in 1 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 8 [hp_X] in 1 mL BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8) BORRELIA BURGDORFERI 12 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 12 [hp_X] in 1 mL PUMPKIN SEED (UNII: GH30P1VXK2) (PUMPKIN SEED - UNII:GH30P1VXK2) PUMPKIN SEED 17 [hp_X] in 1 mL LEMON JUICE (UNII: AGN709ANTJ) (LEMON JUICE - UNII:AGN709ANTJ) LEMON JUICE 18 [hp_X] in 1 mL HIPPEASTRUM PUNICEUM WHOLE (UNII: 025JEQ4O6S) (HIPPEASTRUM PUNICEUM WHOLE - UNII:025JEQ4O6S) HIPPEASTRUM PUNICEUM WHOLE 3 [hp_C] in 1 mL BROMELAINS (UNII: U182GP2CF3) (BROMELAINS - UNII:U182GP2CF3) BROMELAINS 6 [hp_C] in 1 mL AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER 30 [hp_C] in 1 mL ILEX AQUIFOLIUM FLOWERING TOP (UNII: 5ENR9SAN1W) (ILEX AQUIFOLIUM FLOWERING TOP - UNII:5ENR9SAN1W) ILEX AQUIFOLIUM FLOWERING TOP 30 [hp_C] in 1 mL MALUS DOMESTICA FLOWER (UNII: EF626V855K) (MALUS DOMESTICA FLOWER - UNII:EF626V855K) MALUS DOMESTICA FLOWER 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53405-0005-1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/17/2017 07/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/17/2017 07/14/2020 Labeler - InLight Creation, LLC. (078578483) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(53405-0005) , api manufacture(53405-0005) , label(53405-0005) , pack(53405-0005)
