HARMONYHM- argentum nitricum, avena sativa, aurum metallicum, gelsemium sempervirens, hyoscyamus niger, ignatia amara, moschus, natrum muriaticum, passiflora incarnata, stannum metallicum, valeriana officinalis spray 
ONE NATURE LABS 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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HarmonyHM

ACTIVE INGREDIENTS (HPUS*): Argentum Nitricum 8X, 13X, 21X, Avena Sativa 2X, 3X, 5X, 8X, Aurum Metallicum 13X, 21X, Gelsemium Sempervirens 13X, 21X, Hyoscyamus Niger 13X, 21X, Ignatia Amara 13X, 21X, Moschus 13X, 21X, Natrum Muriaticum 13X, 21X, Passiflora Incarnata 2X, 3X, 5X, 8X, Stannum Metallicum 13X, 21X, Valeriana Officinalis 2X, 3X, 5X, 8X.


*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.


USES: Temporarily relieves anxiety, irritability and nervousness due to everyday stress.

"This statement has not been evaluated by the FDA"


WARNING:

KEEP OUT OF THE REACH OF CHILDREN. IF PREGNANT OR BREAST FEEDING, ask a health professional before use. If symptoms worsen or persist, discontinue use and consult with your doctor. Do not use if seal is broken.

Keep out of the reach of children.


DIRECTIONS: Shake 10 times before use. Adults and children above 12 years of age: spray 3-4 times under the tongue every 15 minutes, extend interval as symptoms improve or as directed by a health care professional. Children under 12: use half the adult dose.


INACTIVE INGREDIENTS: Ethanol Alcohol 16%, Glycerin, Purified Water.


Proudly made in the USA - 100% natural ingredients

Distributed by: ONE NATURE LABS, Davie, FL 33331

FDA Pharmaceutical Establishment #3003231743


Relieves anxiety, irritability and nervousness


HOMEOPATHIC MEDICINE

FDA NDC 69608-030-02


HarmonyHM


Natural - Safe - Effective

No side effects


Relieves general weakness and low stamina


2 fl oz (59 mL)

16% alcohol


Product of USA

Pharmaceutical Grade

www.OneNatureLabs.com


2oz bottle label

HARMONYHM 
argentum nitricum, avena sativa, aurum metallicum, gelsemium sempervirens, hyoscyamus niger, ignatia amara, moschus, natrum muriaticum, passiflora incarnata, stannum metallicum, valeriana officinalis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69608-030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE8 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]  in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD13 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT13 [hp_X]  in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER13 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED13 [hp_X]  in 1 mL
MOSCHUS MOSCHIFERUS WHOLE (UNII: W5Y0EFG88O) (MOSCHUS MOSCHIFERUS WHOLE - UNII:W5Y0EFG88O) MOSCHUS MOSCHIFERUS WHOLE13 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE13 [hp_X]  in 1 mL
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP2 [hp_X]  in 1 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN13 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69608-030-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/201511/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/201511/02/2017
Labeler - ONE NATURE LABS INC. (079697213)
Registrant - OHM PHARMA INC. (030572478)
Establishment
NameAddressID/FEIBusiness Operations
OHM PHARMA INC.030572478manufacture(69608-030)

Revised: 11/2017
Document Id: 301b6b2b-bc36-4cbe-95b0-087d6cac7dfc
Set id: ca8e8b7c-2f82-42d4-99a8-640ca3c84be2
Version: 2
Effective Time: 20171102
 
ONE NATURE LABS INC.