Label: TMJ EASE- baptisia tinctoria, calcarea fluorica, causticum, hepar sulphuris calcareum, hypericum perforatum, ignatia amara, kalmia latifolia, nux vomica, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis, symphytum officinale spray
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Contains inactivated NDC Code(s)
NDC Code(s): 68703-104-59 - Packager: Native Remedies, LLC
- Category: HUMAN OTC DRUG LABEL
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 June 27, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- PURPOSE
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ACTIVE INGREDIENT
Drug Facts
Active Ingredients: Equal volumes of each ingredient in 10X, 30X, LM1 potencies: Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amara, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INFORMATION FOR PATIENTS
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States
All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International: 1.561.999.8857No gluten, artificial flavors, animal products, or colorants added
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TMJ EASE
baptisia tinctoria, calcarea fluorica, causticum, hepar sulphuris calcareum, hypericum perforatum, ignatia amara, kalmia latifolia, nux vomica, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis, symphytum officinale sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 10 [hp_X] in 59 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_X] in 59 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] in 59 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 10 [hp_X] in 59 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 in 59 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 10 [hp_X] in 59 mL KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18) KALMIA LATIFOLIA LEAF 10 [hp_X] in 59 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 10 [hp_X] in 59 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 10 [hp_X] in 59 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68703-104-59 59 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/27/2013 Labeler - Native Remedies, LLC (192014186) Establishment Name Address ID/FEI Business Operations King Bio 617901350 manufacture(68703-104) , api manufacture(68703-104)