Label: OHM-INS- avena sativa, coffea cruda, ignatia amara, passiflora incarnata, valeriana officinalis spray
- NDC Code(s): 66096-720-02
- Packager: OHM PHARMA 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 November 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active ingredients (HPUS*): Each 100 mL contains: Avena Sativa 5X, Coffea Cruda 30C,
Ignatia Amara 14X, Passiflora Incarnata 5X, Valeriana Officinalis 5X; 6.0 mL each.*The letters “HPUS” indicate the components in the product are officially monographed in the
Homeopathic Pharmacopoeia of the United States. - INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OHM-INS
avena sativa, coffea cruda, ignatia amara, passiflora incarnata, valeriana officinalis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66096-720 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 5 [hp_X] in 30 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 30 [hp_C] in 30 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 14 [hp_X] in 30 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 5 [hp_X] in 30 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 5 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66096-720-02 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/07/2020 Labeler - OHM PHARMA INC. (030572478)