Label: SLEEP WELL CONTROL- avena sativa flowering top, arabica coffee bean, lavandula angustifolia subsp. angustifolia flower, macropiper methysticum root, and valerian solution/ drops
- NDC Code(s): 51393-4014-4
- Packager: Forces of Nature
- 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 April 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
For external use only. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs. Stop use and consult a doctor if condition worsens. Not for use on children under the age of 2 without physician direction.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
SLEEP WELL CONTROL
avena sativa flowering top, arabica coffee bean, lavandula angustifolia subsp. angustifolia flower, macropiper methysticum root, and valerian solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51393-4014 Route of Administration TOPICAL 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 30 [hp_X] in 100 mL Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean 30 [hp_C] in 100 mL Lavandula Angustifolia Subsp. Angustifolia Flower (UNII: 19AH1RAF4M) (Lavandula Angustifolia Subsp. Angustifolia Flower - UNII:19AH1RAF4M) Lavandula Angustifolia Subsp. Angustifolia Flower 12 [hp_C] in 100 mL Macropiper Methysticum Root (UNII: BOW48C81XP) (Macropiper Methysticum Root - UNII:BOW48C81XP) Macropiper Methysticum Root 30 [hp_C] in 100 mL Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 12 [hp_C] in 100 mL Inactive Ingredients Ingredient Name Strength Sesame Oil (UNII: QX10HYY4QV) Lavandin Oil (UNII: 9RES347CKG) Clary Sage Oil (UNII: 87L0D4U3M0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51393-4014-4 1 in 1 CARTON 09/01/2018 1 4 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 09/01/2018 Labeler - Forces of Nature (050169130)