Label: BABY GUM RELIEF- calcium fluoride, chamomile, ferrum phosphoricum, oyster shell calcium carbonate, crude, podophyllum and tribasic calcium phosphate tablet, orally disintegrating

  • 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 August 9, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Calcarea carbonica (Calcium) 12Xpain, difficult dentition
    Calcarea fluorica (Calcium) 12Xsupports dental development
    Calcarea phosphorica (Calcium) 12Xsupports dental development, pain, slow dentition
    Chamomilla (Chamomile) 8Xswelling, irritability, restlessness, sleeplessness, red cheek/face
    Ferrum phosphoricum 12Xpain
    Podophyllum peltatum (May Apple) 12Xdrooling, chewing on things, irritability, fussiness or restlessness
  • Uses1

    According to homeopathic principles, the active ingredients in this product:

    • temporarily relieve restlessness & irritability due to painful gums
    • support dental development
    1
    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
  • Warnings

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
    • Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.
    • Do not exceed recommended dosage.
    • As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.

    Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

  • Directions

    Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

  • Other information

    Active ingredients are manufactured according to homeopathic principles.

    Do not use if tamper evident seal beneath cap is broken or missing.

    For more information, see http://www.similasanUSA.com/about-homeopathy

  • Inactive ingredients

    Crospovidone, Mannitol, Sodium stearyl fumarate

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Similasan Corp., Highlands Ranch, CO 80129

  • PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box

    NDC 59262-502-26

    BELLADONNA
    FREE

    Similasan®

    Baby Gum
    Relief

    QUICK DISSOLVING TABLETS

    Formulated with
    NATURAL ACTIVE INGREDIENTS

    BABY

    • Chamomile for Irritability*
    • Triple Calcium Blend Supports
      Development of Healthy Teeth*
    • Benzocaine Free • Belladonna Free

    HOMEOPATHIC
    The Swiss Original

    135 Quick Dissolving
    Tablets (actual size)

    PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box
  • INGREDIENTS AND APPEARANCE
    BABY GUM RELIEF 
    calcium fluoride, chamomile, ferrum phosphoricum, oyster shell calcium carbonate, crude, podophyllum and tribasic calcium phosphate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-502
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE8 [hp_X]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-502-261 in 1 BOX06/15/2018
    1135 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/15/2018
    Labeler - Similasan Corporation (111566530)
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