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.

Drug Label Information

Updated 07/10

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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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
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  • Uses

    temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and older

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  • Warnings

    Do not use more than directed.

    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.

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  • Directions

    • 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.
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  • 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.
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  • Inactive ingredients

    citric acid, glycerin, purified water, sodium benzoate

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  • Questions?

    call 1-800-344-7239 or visit our website at www.gentlenaturals.com

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749

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  • PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton

    Gentle
    Naturals
    ®

    Homeopathic
    Teething Drops

    Relieves Teething Pain
    100% Natural with Chamomile
    with No Known Side Effects

    1 FL OZ (29.6 mL)

    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 liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63736-318
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Matricaria Recutita (Matricaria Recutita) Matricaria Recutita 30 [hp_X]  in 1 mL
    Tribasic Calcium Phosphate (Calcium Cation) Tribasic Calcium Phosphate 6 [hp_X]  in 1 mL
    Potassium Phosphate, Dibasic (Potassium Cation) Potassium Phosphate, Dibasic 6 [hp_X]  in 1 mL
    Magnesium Phosphate, Dibasic Trihydrate (Magnesium Cation) Magnesium Phosphate, Dibasic Trihydrate 6 [hp_X]  in 1 mL
    Delphinium Staphisagria Seed (Delphinium Staphisagria Seed) Delphinium Staphisagria Seed 9 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid Monohydrate  
    Glycerin  
    Water  
    Sodium Benzoate  
    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)
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