BODY BALANCE- avena sativa, chlorophytum borivilianum, nuphar luteum, punica granatum, spermidine, spermine, damiana, selenium m

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F), ASPARAGUS ADSCENDENS ROOT (UNII: PCV2634GQH) (ASPARAGUS ADSCENDENS ROOT - UNII:PCV2634GQH), NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D), POMEGRANATE (UNII: 56687D1Z4D) (POMEGRANATE - UNII:56687D1Z4D), SPERMIDINE (UNII: U87FK77H25) (SPERMIDINE - UNII:U87FK77H25), SPERMINE (UNII: 2FZ7Y3VOQX) (SPERMINE - UNII:2FZ7Y3VOQX), TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA L
Available from:
Energique, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic 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.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration. 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.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Authorization status:
unapproved homeopathic
Authorization number:
44911-0110-1

BODY BALANCE- avena sativa, chlorophytum borivilianum, nuphar luteum, punica granatum,

spermidine, spermine, damiana, selenium metallicum, staphysagria, thuja occidentalis liquid

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.

----------

DRUG FACTS:

ACTIVE INGREDIENTS:

Avena Sativa 3X, Chlorophytum Borivilianum 3X, Nuphar Luteum 6X, Punica Granatum (Fruit) 6X,

Spermidine 6X, 12X, 30X, 12C, 30C, Spermine 6X, 12X, 30X, 12C, 30C, Damiana 9X, Selenium

Metallicum 9X, Staphysagria 9X, Thuja Occidentalis 12X.

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.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by

the Food and Drug Administration.

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:

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 3 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.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by

the Food and Drug Administration.

INACTIVE INGREDIENTS:

Citric Acid, Demineralized Water, 25% Ethanol, Spermidine, Spermine.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

PACKAGE DISPLAY LABEL:

ENERGIQUE

HOMEOPATHIC REMEDY

BODY BALANCE

1 fl. oz. (30 ml) 25% Ethanol

BODY BALANCE

avena sativa, chlorophytum borivilianum, nuphar luteum, punica granatum, spermidine, spermine, damiana, selenium

metallicum, staphysagria, thuja occidentalis liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:449 11-0 110

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVENA SATIVA FLO WERING TO P (UNII: MA9 CQJ3F7F) (AVENA SATIVA FLOWERING

TOP - UNII:MA9 CQJ3F7F)

AVENA SATIVA

FLOWERING TOP

3 [hp_X]

in 1 mL

ASPARAGUS ADSCENDENS RO O T (UNII: PCV26 34GQH) (ASPARAGUS ADSCENDENS

ROOT - UNII:PCV26 34GQH)

ASPARAGUS

ADSCENDENS ROOT

3 [hp_X]

in 1 mL

NUPHAR LUTEUM RO O T (UNII: 714LIU3V6 D) (NUPHAR LUTEUM ROOT -

UNII:714LIU3V6 D)

NUPHAR LUTEUM ROOT

6 [hp_X]

in 1 mL

PO MEGRANATE (UNII: 56 6 8 7D1Z4D) (POMEGRANATE - UNII:56 6 8 7D1Z4D)

POMEGRANATE

6 [hp_X]

in 1 mL

SPERMIDINE (UNII: U8 7FK77H25) (SPERMIDINE - UNII:U8 7FK77H25)

SPERMIDINE

6 [hp_X]

in 1 mL

Energique, Inc.

SPERMINE (UNII: 2FZ7Y3VOQX) (SPERMINE - UNII:2FZ7Y3VOQX)

SPERMINE

6 [hp_X]

in 1 mL

TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY

TWIG - UNII:RQ2CFA7WWJ)

TURNERA DIFFUSA

LEAFY TWIG

9 [hp_X]

in 1 mL

SELENIUM (UNII: H6 241UJ22B) (SELENIUM - UNII:H6 241UJ22B)

SELENIUM

9 [hp_X]

in 1 mL

DELPHINIUM STAPHISAGRIA SEED (UNII: 0 0 543AP1JV) (DELPHINIUM STAPHISAGRIA

SEED - UNII:0 0 543AP1JV)

DELPHINIUM

STAPHISAGRIA SEED

9 [hp_X]

in 1 mL

THUJA O CCIDENTALIS LEAF (UNII: 0 T0 DQN8 78 6 ) (THUJA OCCIDENTALIS LEAF -

UNII:0 T0 DQN8 78 6 )

THUJA OCCIDENTALIS

LEAF

12 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:449 11-0 110 -1

30 mL in 1 BOTTLE, SPRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

12/0 2/20 13

Labeler -

Energique, Inc. (789886132)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(449 11-0 110 ) , api manufacture(449 11-0 110 ) , label(449 11-0 110 ) , pack(449 11-

0 110 )

Revised: 12/2013

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