Label: BODY BALANCE (avena sativa, chlorophytum borivilianum, nuphar luteum, hypothalamus suis, orchitinum- suis, damiana, selenium metallicum, staphysagria, thuja occidentalis spray
- NDC Code(s): 44911-0635-1
- Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated February 14, 2024
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- ACTIVE INGREDIENTS:
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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:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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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:
- QUESTIONS:
- PACKAGE DISPLAY LABEL:
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INGREDIENTS AND APPEARANCE
BODY BALANCE
avena sativa, chlorophytum borivilianum, nuphar luteum, hypothalamus suis, orchitinum (suis), damiana, selenium metallicum, staphysagria, thuja occidentalis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0635 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 3 [hp_X] in 1 mL CHLOROPHYTUM BORIVILIANUM WHOLE (UNII: B0MD133CE7) (CHLOROPHYTUM BORIVILIANUM WHOLE - UNII:B0MD133CE7) CHLOROPHYTUM BORIVILIANUM WHOLE 3 [hp_X] in 1 mL PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (PUNICA GRANATUM ROOT BARK - UNII:CLV24I3T1D) PUNICA GRANATUM ROOT BARK 6 [hp_X] in 1 mL NUPHAR LUTEA ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEA ROOT - UNII:714LIU3V6D) NUPHAR LUTEA ROOT 6 [hp_X] in 1 mL BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS 6 [hp_X] in 1 mL SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE 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: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 9 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 9 [hp_X] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0635-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/16/2021 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0635) , api manufacture(44911-0635) , label(44911-0635) , pack(44911-0635)
