| NDC | 70773-103-30 |
| Set ID | 61566222-27b7-32d2-e053-2a91aa0a11b0 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | PRIVATE LABEL BRANDS CC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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ACTIVE INGREDIENTS (OTC-ACTIVE INGREDIENT SECTION)
Aconitum napellus D60 HPUS
Arnica montana D60 HPUS
Chamomilla (Matricaria recutita) D6 HPUS
Gelsemium sempervirens D60 HPUS
Ignatia amara D12 HPUS
Melissa officinalis D3 HPUS
Phosphoricum acidum D60 HPUS
Five Flower Essences 5x containing:
Clematis vitalba (Clematis) flos. aq. inf.
Helianthemum nummularium (Rock rose) flos. aq. inf.
Impatiens glandulifera (Impatiens) flos. aq. inf.
Ornithogalum umbellatum (Star of Bethlehem) flos. aq. inf.
Prunus cerasifera (Cherry Plum) flos. aq. inf. HPUS
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PURPOSE (DOSAGE & ADMINISTRATION SECTION)
Temporarily relieves fear, extreme anxiety, and panic
Temporarily relieves dizziness and faintness due to trauma or shock
Temporarily calms restlessness, insomnia, tension and stress
Temporarily relieves anticipatory fears, fear of failure and exam fears
Temporarily relieves symptoms of worry, anxiety or hysteria, after shock, grief, emotions of turmoil
Temporarily relieves irritability, coping with stress and tension
Helps to temporarily calm restlessness, insomnia, tension and stress
The five flower essences are used as first aid for the temporary relief of shock and trauma, extreme fear and panic.
It works on the nervous system to retain calmness, temporarily relieve restlessness and impatience
- USES (OTC- PURPOSE SECTION)
- KEEP OUT OF REACH OF CHILDREN (KEEP OUT OF REACH OF CHILDREN SECTION)
- DIRECTIONS (INDICATIONS & USAGE SECTION)
- OTHER INFORMAITON (INSTRUCTIONS FOR USE SECTION)
- WARNING (WARNINGS SECTION)
- STOP USE AND ASK DOCTOR IF (OTC- STOP USE SECTION)
- IF PREGNANT OR BREASTFEEDING, (OTC- PREGNANCY OR BREAST FEEDING SECTION)
- INACTIVE INGREDIENTS (INACTIVE INGREDIENT SECTION)
- Principle Display Panel-30ml container
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INGREDIENTS AND APPEARANCE
RSQ FIVE
aconitum napellus, arnica montana, chamomilla, gelsemium sempervirens, ignatia amara, melissa officinalis, phosphoricum acidum, clematis vitalba, helianthemum nummularium, impatiens glandulifera, ornithogalum umbellatum, prunus cerasifera liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70773-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 60 [hp_X] in 100 [hp_X] ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 60 [hp_X] in 100 [hp_X] MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 100 [hp_X] ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B) ORNITHOGALUM UMBELLATUM FLOWERING TOP 5 [hp_X] in 100 [hp_X] IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER 5 [hp_X] in 100 [hp_X] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 60 [hp_X] in 100 [hp_X] MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS 3 [hp_X] in 100 [hp_X] PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER 5 [hp_X] in 100 [hp_X] GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE 60 [hp_X] in 100 [hp_X] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 12 [hp_X] in 100 [hp_X] HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER 5 [hp_X] in 100 [hp_X] CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER 5 [hp_X] in 100 [hp_X] Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70773-103-30 1 in 1 CARTON 12/25/2017 1 1 [hp_X] in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/25/2017 Labeler - PRIVATE LABEL BRANDS CC (539043103) Registrant - PRIVATE LABEL BRANDS CC (539043103) Establishment Name Address ID/FEI Business Operations Herbal and Homeopathic (Pty) Ltd. 638215520 manufacture(70773-103)
