Label: GENTLE NATURALS- matricaria recutita, tribasic calcium phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate and delphinium staphisagria seed liquid
- NDC Code(s): 63736-318-24
- Packager: Insight Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- 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
temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and olderClose
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.
Stop use and ask a physician or dentist if
- sore mouth symptoms do not get better in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash or fever develops
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
- children and infants over 4 months of age, place one half dropper (0.5mL) under the tongue every 2 hours. Once symptoms improve reduce to 4 times daily.
- for infants under 4 months of age, ask a physician or dentist.
- Other information
- Do not use if white neck band printed with "sealed for your protection" is broken or missing.
- Store tightly closed at room temperature 15°-25°C (59°-77°F).
- Keep carton for full drug facts.
- Inactive ingredients
citric acid, glycerin, purified water, sodium benzoateClose
call 1-800-344-7239 or visit our website at www.gentlenaturals.comClose
- SPL UNCLASSIFIED SECTION
INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749Close
- PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton
Relieves Teething Pain
100% Natural with Chamomile
with No Known Side Effects
1 FL OZ (29.6 mL)
- INGREDIENTS AND APPEARANCE
matricaria recutita, tribasic calcium phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, and delphinium staphisagria seed liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-318 Route of Administration ORAL DEA Schedule 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)