NEURO CALMING FORMULA- avena sativa, humulus lupulus, passiflora incarnata, valeriana officinalis, ignatia amara, scutellaria lateriflora, zincum metallicum spray 
Nutritional Specialties, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Avena Sativa 2X, Humulus Lupulus 2X, Passiflora Incarnata 2X, Valeriana Officinalis 2X, Ignatia Amara 6X, Scutellaria Lateriflora 6X, Zincum Metallicum 12X.

PURPOSE:

For temporary relief of the effects of anxiety and stress-related conditions; sleep enhancer.†

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

WARNINGS:

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

KEEP OUT OF REACH OF CHILDREN:

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of the effects of anxiety and stress-related conditions; sleep enhancer.†

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

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0013-1

NEURO CALMING

FORMULA

2 FL. OZ (60 ml)

NEURO CALMING FORMULA

NEURO CALMING FORMULA 
avena sativa, humulus lupulus, passiflora incarnata, valeriana officinalis, ignatia amara, scutellaria lateriflora, zincum metallicum spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]  in 1 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS2 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_X]  in 1 mL
SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA WHOLE - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA WHOLE6 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83027-0013-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/21/2023
Labeler - Nutritional Specialties, Inc. (032744609)

Revised: 2/2023
Document Id: 53dde9e7-3e52-482b-9dc3-e4e43266e4fd
Set id: ff9b8811-1883-42bc-bcf4-7b390237a619
Version: 1
Effective Time: 20230221
 
Nutritional Specialties, Inc.