RESCUE SLEEP KIDS- rescue remedy spray

Rescue Sleep Kids by

Drug Labeling and Warnings

Rescue Sleep Kids by is a Homeopathic medication manufactured, distributed, or labeled by Nelson Bach USA Limited, Nelson & Co. Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts - Active Ingredients

Drug Facts

Active Ingredients (Each: equal parts 5X HPUS)

Purpose

Cherry Plum (Prunus cerasifera) - Balanced mind when losing control

Clematis (Clematis vitalba) - Focus when undgrounded

Impatiens (Impatiens glandulifera) - Patience with problems & people

Rock Rose (Helianthemum nummularium) - Courage & presence of mind

Star of Bethlehem (Ornithogalum umbellatum) - Softens impact of shock

White Chestnut (Aesculus hippocastanum) - Relief from repetitive thoughts

'HPUS' indicates ingredients are in the official Homeopathic Pharmacopoeia of the United States

Use

Use

recommended for relief of occasional sleeplessness caused by stress & repetitive thoughts 1

1 Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

Warnings

Stop use and ask a doctor if sleeplessness persists for more than 2 weeks: insomnia can be a symptom of a serious underlying
medical illness.
When using, keep away from eyes.
Keep out of reach of children.

Use only under adult supervision.

Directions

Directions

children ages 2 & up: before bedtime, bring spray nozzle up to mouth & apply 2 sprays onto the tongue. Additional sprays may be
taken during the night as needed

children under 2: ask a doctor

Other Information

Other information

store below 77ºF (25ºC)

Inactive Ingredients

Inactive ingredients

glycerin [vegetable], purified water

Questions

(800) 319-9151 Mon-Fri 8am-5pm (EST)

Distributed by

Dist by

Nelson Bach USA, LTD, N. Andover, MA 01845

OTC Purpose

For the relief of occasional sleplessness

Keep out of reach of children

Keep out of reach of children

Primary display panel - Rescue Spray Kids

Rescue Sleep Kids

NDC: 57687-335-20

MELATONIN-FREE

Bach ®

ORIGINAL
FLOWER REMEDIES

RESCUE SLEEP®
SPRAY KIDS

SLEEP AID

WITH Bach ®
NATURAL
FLOWER ESSENCES

0.7 fl oz (20mL)

Homeopathic

*See disclaimer
on back panel

INGREDIENTS AND APPEARANCE

RESCUE SLEEP KIDS 
rescue remedy spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57687-335
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B)	ORNITHOGALUM UMBELLATUM FLOWERING TOP	5 [hp_X]  in 0.095 mL
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA FLOWER	5 [hp_X]  in 0.095 mL
CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI)	CLEMATIS VITALBA FLOWER	5 [hp_X]  in 0.095 mL
HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP)	HELIANTHEMUM NUMMULARIUM FLOWER	5 [hp_X]  in 0.095 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	5 [hp_X]  in 0.095 mL
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	5 [hp_X]  in 0.095 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57687-335-20	1 in 1 CARTON	09/03/2024
1		20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/03/2024

Labeler - Nelson Bach USA Limited (877720193)

Registrant - Nelson & Co. Limited (221471234)

Establishment
Name	Address	ID/FEI	Business Operations
Nelson & Co. Limited		221471234	manufacture(57687-335)