Label: GENTLE NATURALS- matricaria recutita, tribasic calcium phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, and delphinium staphisagria seed liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63736-318-24 - Packager: Insight Pharmaceuticals
- 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 July 6, 2010
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- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients Purpose Chamomilla (Chamomile) 3X, 6X, 12X, 30X pain and sensitivity of teething, calming Calcarea Phosphorica (Calcium Phosphate) 6X pain and sensitivity of teething Kali Phosphoricum (Potassium Phosphate) 6X pain in mouth and gums Magnesia Phosphorica (Magnesium Phosphate) 6X pain and sensitivity of teething Staphysagria (Delphinium Staphisagria) 9X pain and sensitivity of teething - Uses
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Warnings
When using this product
- fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician or dentist.
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
GENTLE NATURALS
matricaria recutita, tribasic calcium phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, and delphinium staphisagria seed liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-318 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 30 [hp_X] in 1 mL Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) (Calcium Cation - UNII:2M83C4R6ZB) Tribasic Calcium Phosphate 6 [hp_X] in 1 mL Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Potassium Cation - UNII:295O53K152) Potassium Phosphate, Dibasic 6 [hp_X] in 1 mL Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate 6 [hp_X] in 1 mL Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed 9 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Sodium Benzoate (UNII: OJ245FE5EU) Product Characteristics Color WHITE (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-318-24 24 in 1 CASE 1 1 in 1 BOX 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 06/20/2010 Labeler - Insight Pharmaceuticals (176792315)