Calm Remedy Water
FDA Label NDC 35378-0004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Georgetown Health, Llc Dba Essentialife for the product Calm Remedy Water (NDC 35378-0004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, inactive ingredients, other information, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Aconitum napellus15x
Argentum nitricum15x
Aurum metallicum15x
Baptisia15x
Bryonia 15x
Chelidonium majus15x
Cimicifuga racemosa15x
Conium maculatum15x
Gelsemium sempervirens15x
Ignatia amara15x
Kali carbonicum15x
Lachesis mutus15x
Lilum tigrinum15x
Lycopodium clavatum15x
Natrum carbonicum15x
Natrum muriaticum15x
Phosphoricum acidum15x
Phosphorus15x
Picricum acidum15x
Plumbum metallicum15x
Sepia15x
Staphysagria15x
Stramonium15x
Thuja occidentalis15x
Zincum metallicum15x
Chamomilla  3x
Hypericum perforatum  3x
Valeriana officinalis  3x

Purpose

Formulated for symptoms associated with stress and tension such as worry, frustration, emotional sensitivity and feeling mentally and physically drained.

Uses

Formulated for symptoms associated with stress and tension such as worry, frustration, emotional sensitivity and feeling mentally and physically drained.

Warnings

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.

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.

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)

Other Information

 Avoid storing in areas where temperatures may exceed 140 degrees.

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. SHAKE

Please Recyle

Patent Pending

Boosted by PowerCap®

FDA Registered and Regulated

NO PRESERVATIVES

ZERO CALORIES

BPA-FREE BOTTLE

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, 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

www.RemedyWater.com

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.

Calm Water Label (Ew02 01g)

Calm Water Label (Ew02 01g)

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