Label: GENTLE NATURALS- matricaria recutita, tribasic calcium phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, and delphinium staphisagria seed liquid

  • 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

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Chamomilla (Chamomile) 3X, 6X, 12X, 30Xpain and sensitivity of teething, calming
    Calcarea Phosphorica (Calcium Phosphate) 6X pain and sensitivity of teething
    Kali Phosphoricum (Potassium Phosphate) 6Xpain in mouth and gums
    Magnesia Phosphorica (Magnesium Phosphate) 6Xpain and sensitivity of teething
    Staphysagria (Delphinium Staphisagria) 9Xpain and sensitivity of teething
  • Uses

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

  • 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.

  • 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.
  • 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 benzoate

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749

  • 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
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita30 [hp_X]  in 1 mL
    Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) (Calcium Cation - UNII:2M83C4R6ZB) Tribasic Calcium Phosphate6 [hp_X]  in 1 mL
    Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Potassium Cation - UNII:295O53K152) Potassium Phosphate, Dibasic6 [hp_X]  in 1 mL
    Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate6 [hp_X]  in 1 mL
    Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed9 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorWHITE (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-318-2424 in 1 CASE
    11 in 1 BOX
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/20/2010
    Labeler - Insight Pharmaceuticals (176792315)
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