Label: B-SERENE RX- pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch
- NDC Code(s): 69833-030-30
- Packager: Spring Hill Therapeutics LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated January 14, 2016
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- STATEMENT OF IDENTITY
For external use only • Use only as directed • Avoid contact with eyes and mucous membranes • Do not use with heating devices or pads • Do not bandage tightly • If contact does occur with eyes rinse with cold water and call a doctor • Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and any drugs, herbs and/or supplements consumption should be considered. • Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Concomitant use of ginger in pateints with heavy bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.
- Inactive Ingredients
Do not use
On wounds or damaged skin. Children under 12 years old, consult a doctor. If you are allergic to any ingredients in this product. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Keep out of the reach of children.
- Other Information
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 30 Patch Bag Label
INGREDIENTS AND APPEARANCE
pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69833-030 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 75 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1200 ug Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 500 mg Inactive Ingredients Ingredient Name Strength 2-Ethylhexyl Acrylate (UNII: HR49R9S6XG) Methacrylic Acid (UNII: 1CS02G8656) Bentonite (UNII: A3N5ZCN45C) Sodium Stearate (UNII: QU7E2XA9TG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69833-030-30 30 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/05/2015 Labeler - Spring Hill Therapeutics LLC (079813250)