BODY BALANCE- avena sativa, chlorophytum borivilianum, nuphar luteum, hypothalamus suis, orchitinum (suis), damiana, selenium metallicum, staphysagria, thuja occidentalis spray 
Energique, 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:

(in each spray): 6.64% of Damiana 9X, Granatum 6X, Hypothalamus Suis 6X, 12X, 30X, 12C, 30C, Nuphar Luteum 6X, Orchitinum (Suis) 6X, 12X, 30X, 12C, 30C, Staphysagria 9X, Thuja Occidentalis 12X;0.10% of Avena Sativa 3X, Chlorophytum Borivilianum 3X, Selenium Metallicum 9X.

INDICATIONS:

Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.**

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

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

Adults only. Spray 2 times under the tongue 2 times a day. If symptoms persist, consult your health care professional.

INDICATIONS:

Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.**

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

INACTIVE INGREDIENTS:

Citric acid, Demineralized water, 25% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

PACKAGE DISPLAY LABEL:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BODY BALANCE

1 fl. oz. (30 ml) 

Body Balance

BODY BALANCE 
avena sativa, chlorophytum borivilianum, nuphar luteum, hypothalamus suis, orchitinum (suis), damiana, selenium metallicum, staphysagria, thuja occidentalis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0635
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 TOP3 [hp_X]  in 1 mL
CHLOROPHYTUM BORIVILIANUM WHOLE (UNII: B0MD133CE7) (CHLOROPHYTUM BORIVILIANUM WHOLE - UNII:B0MD133CE7) CHLOROPHYTUM BORIVILIANUM WHOLE3 [hp_X]  in 1 mL
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (PUNICA GRANATUM ROOT BARK - UNII:CLV24I3T1D) PUNICA GRANATUM ROOT BARK6 [hp_X]  in 1 mL
NUPHAR LUTEA ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEA ROOT - UNII:714LIU3V6D) NUPHAR LUTEA ROOT6 [hp_X]  in 1 mL
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS6 [hp_X]  in 1 mL
SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE6 [hp_X]  in 1 mL
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG9 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM9 [hp_X]  in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED9 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0635-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/16/2021
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0635) , api manufacture(44911-0635) , label(44911-0635) , pack(44911-0635)

Revised: 2/2024
Document Id: a35365e2-3091-45cd-acde-e02a0b0a779a
Set id: d8e70220-b3ef-4595-a8c3-a77a6bd373e4
Version: 3
Effective Time: 20240214
 
Energique, Inc.