Label: COMFORT FOR TEETHING 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 December 28, 2023

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  • Directions for Use:

    Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.

  • Ingredients, Active:

    Chamomilla (Chamomile) 3X, Arnica montana (Arnica) 6X, Calcarea phosphorica (Calcium phosphate)6x, Kreosotum (Creosote) 6X, Magensia phosphorica (Magnesium phosphate) 6X, Rheum (Rhubarb) 6X.

  • Inactive ingredients

    USP Purified water, Vegetable glycerine

  • Warnings:

    Do not use for more than 7 days unless directed by a physician. Stop use and ask a doctor if

    • symptoms do not improve in 7 days
    • swelling, rash, or fever develops
    • irritiation, pain or redness persists or worsens

    If pregnant or nursing, ask a doctor before use

  • Indications:

    For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething.

  • Comments or Questions

    Health for Kids Shelbourne Falls, MA 01370 USA

    1-800-255-4463

    www.herbsforkids.com

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething

  • PRINCIPAL DISPLAY PANEL

    comfort for teething label.jpg

    Label

  • INGREDIENTS AND APPEARANCE
    COMFORT FOR TEETHING 
    comfort for teething liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED (UNII: W30T5D628Q) (MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED - UNII:W30T5D628Q) MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED6 [hp_X]  in 0.05 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE3 [hp_X]  in 0.05 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 0.05 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION6 [hp_X]  in 0.05 mL
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE6 [hp_X]  in 0.05 mL
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT6 [hp_X]  in 0.05 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-115-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/05/2013
    Labeler - Vitality Works, Inc. (137752817)
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