NDC | 35378-0004-2, 35378-0004-3 |
Set ID | 4c339673-d171-cba4-29f3-1bee209976cf |
Category | HUMAN OTC DRUG LABEL |
Packager | Georgetown Health, LLC DBA EssentiaLife |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Drug Facts
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Active Ingredients
Aconitum napellus 15x Argentum nitricum 15x Aurum metallicum 15x Baptisia 15x Bryonia 15x Chelidonium majus 15x Cimicifuga racemosa 15x Conium maculatum 15x Gelsemium sempervirens 15x Ignatia amara 15x Kali carbonicum 15x Lachesis mutus 15x Lilum tigrinum 15x Lycopodium clavatum 15x Natrum carbonicum 15x Natrum muriaticum 15x Phosphoricum acidum 15x Phosphorus 15x Picricum acidum 15x Plumbum metallicum 15x Sepia 15x Staphysagria 15x Stramonium 15x Thuja occidentalis 15x Zincum metallicum 15x Chamomilla 3x Hypericum perforatum 3x Valeriana officinalis 3x - Purpose
- Uses
- Warnings
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Directions
Ages 12 and up. Remedy Water® homepathic pellets are dispersed via the PowerCap® apparatus. Firmly press PowerCap® dome to release pellets into the bottle of water and shake well. Remedy Water® pellets may not dissolve completely. Drink within four hours. Avoid storing or washing where temperatures may exceed 140 degrees.
- KEEP OUT OF REACH OF CHILDREN
- Inactive Ingredients
- Other Information
- Questions?
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PRINCIPAL DISPLAY PANEL
NDC# 35378-0004-2
EssentiaLIFE Homeopathics™
CALM Remedy Water®
Formulated for symptoms associated with stress and tension such as frustration, worry, emotional sensitivity and feeling mentally and physically drained.
Seven PowerCaps® - 1 gram each
Directions: Ages 12 and up. Remedy Water® homepathic pellets are dispersed via the PowerCap® apparatus. Firmly press PowerCap® dome to release pellets into the bottle of water and shake well. Remedy Water® pellets may not dissolve completely. Drink within four hours. Avoid storing or washing where temperatures may exceed 140 degrees.
IT'S ALL IN THE CAP
NEVER A PRESERVATIVE
1. PUSH
2. SHAKEPlease Recyle
Patent Pending
Boosted by PowerCap®
FDA Registered and Regulated
NO PRESERVATIVES
ZERO CALORIES
BPA-FREE BOTTLEActive Ingredients: Aconitum napellus 15x, Argentum nitricum 15x, Aurum metallicum 15x, Baptisia 15x, Bryonia 15x, Chelidonium majus 15x, Cimicifuga racemosa 15x, Conium maculatum 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali carbonicum 15x, Lachesis mutus 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Natrum carbonicum 15x, Natrum muriaticum 15x, Phosphoricum acidum 15x, Phosphorus 15x, Picricum acidum 15x, Plumbum metallicum 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Thuja occidentalis 15x, Zincum metallicum 15x, Chamomilla 3x, Hypericum perforatum 3x, Valeriana officinalis 3x.
Inactive ingredients: USP/NF neutral pellets (.07% gluten-free, non-GMO, beet-derived sucrose, .03% gluten-free, non-GMO maize starch in 500 ml water)
Stock# EW02
Lot# 01GEW02
Distributed by EssentiaLIFE
FDA Est.# 3006407415 Atlanta, GA 30328
Questions?
1.866.777.1277
Warning: Do not use if tamper-evident package seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
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INGREDIENTS AND APPEARANCE
CALM REMEDY WATER
aconitum nap., arg. nit., aut. met., baptisia, bryonia, chelidonium majus, cimicifuga, conium, gelsemium, ignatia, kali carb., lachesis, lilum, lycopodium, nat. carb., nat. mur., phosphoricum ac., phosphorus, picricum ac., plumb. met., sepia, staphysag., stramonium, thuja occ., zinc. met., chomomilla, hypericum, valeriana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35378-0004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 15 [hp_X] in 1 mg Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 15 [hp_X] in 1 mg Gold (UNII: 79Y1949PYO) (Gold - UNII:79Y1949PYO) Gold 15 [hp_X] in 1 mg Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root 15 [hp_X] in 1 mg Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 mg Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 15 [hp_X] in 1 mg Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh 15 [hp_X] in 1 mg Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top 15 [hp_X] in 1 mg Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X] in 1 mg Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed 15 [hp_X] in 1 mg Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate 15 [hp_X] in 1 mg Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X] in 1 mg Lilium Lancifolium Bulb (UNII: 47Z05W73EZ) (Lilium Lancifolium Bulb - UNII:47Z05W73EZ) Lilium Lancifolium Bulb 15 [hp_X] in 1 mg Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 mg Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate 15 [hp_X] in 1 mg Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride 15 [hp_X] in 1 mg Phosphoric Acid (UNII: E4GA8884NN) (Phosphoric Acid - UNII:E4GA8884NN) Phosphoric Acid 15 [hp_X] in 1 mg Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X] in 1 mg Trinitrophenol (UNII: A49OS0F91S) (Trinitrophenol - UNII:A49OS0F91S) Trinitrophenol 15 [hp_X] in 1 mg Lead (UNII: 2P299V784P) (Lead - UNII:2P299V784P) Lead 15 [hp_X] in 1 mg Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 15 [hp_X] in 1 mg Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed 15 [hp_X] in 1 mg Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium 15 [hp_X] in 1 mg Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig 15 [hp_X] in 1 mg Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 15 [hp_X] in 1 mg Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 3 [hp_X] in 1 mg Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 3 [hp_X] in 1 mg Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 3 [hp_X] in 1 mg Inactive Ingredients Ingredient Name Strength Starch, Corn (UNII: O8232NY3SJ) Sucrose (UNII: C151H8M554) Product Characteristics Color WHITE Score no score Shape ROUND Size 1mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35378-0004-2 7 in 1 CONTAINER 1 1000 mg in 1 CYLINDER 2 NDC:35378-0004-3 1 in 1 CONTAINER 2 1000 mg in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2012 Labeler - Georgetown Health, LLC DBA EssentiaLife (111513086) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(35378-0004)