MedPath
FDA Approval

Rescue Remedy (Instant Calm)

Bestmade Natural Products (DUNS: 047124582)

May 27, 2025

HUMAN OTC DRUG LABEL

helianthemum nummularium flower(5 [hp_X] in 30 mL)
impatiens glandulifera flower(5 [hp_X] in 30 mL)
clematis vitalba flower(5 [hp_X] in 30 mL)
ornithogalum umbellatum bulb(5 [hp_X] in 30 mL)
prunus cerasifera flower(5 [hp_X] in 30 mL)

Manufacturing Establishments (1)

Total Operations Management LLC DBA: Bestmade Natural Products Micro

Bestmade Natural Products

047124582

Products (1)

Rescue Remedy (Instant Calm)

82969-6025

ORAL

May 27, 2025

ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 30 mL in 30 mL
helianthemum nummularium flowerActive
Code: 51BRR32WPPClass: ACTIBQuantity: 5 [hp_X] in 30 mL
impatiens glandulifera flowerActive
Code: AJU5O1A5ZVClass: ACTIBQuantity: 5 [hp_X] in 30 mL
clematis vitalba flowerActive
Code: 7SCP4N87CIClass: ACTIBQuantity: 5 [hp_X] in 30 mL
ornithogalum umbellatum bulbActive
Code: 48TG5UWC7ZClass: ACTIBQuantity: 5 [hp_X] in 30 mL
prunus cerasifera flowerActive
Code: 0KD7R09EASClass: ACTIBQuantity: 5 [hp_X] in 30 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

entire package label

Rescue Remedy (Instant Calm) Spray


INDICATIONS & USAGE SECTION

Use for:

Temporarily relieves nervousness, frustration, sleeplessness, and stress.

Temporarily supports calm, comfort, and focus.*

DOSAGE & ADMINISTRATION SECTION

How to use:
Apply 2 sprays onto the tongue. Additional sprays may be taken as needed.


WARNINGS SECTION

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.


OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Cherry Plum (Prunus Cerasifera)
Clematis (Clematis Vitalba)
Impatiens (Impatiens Glandulifera)
Rock Rose (Helianthemum Nummularium)
Star of Bethlehem (Ornithogalum Umbellatum)

OTC - PURPOSE SECTION

Use for:

Temporarily relieves nervousness, frustration, sleeplessness, and stress.

Temporarily supports calm, comfort, and focus.*

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.


INACTIVE INGREDIENT SECTION

Ingredients:
Inactive: Alcohol Base to Preserve Remedy


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