Label: NUBY SOOTHING GEL- soothing gel gel

  • 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 June 13, 2018

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  • Active Ingredients

    Active ingredients

    Arnica Montana, radix 30X HPUS 3.33%

    Calcarea Phosphorica 12X HPUS 3.33%

    Chamomilla 12X HPUS 3.33%

    The letters “HPUS” indicate that the components in this product are officially monographed in the

    Homeopathic Pharmacopoeia of the United States.

    Active Ingredients

    Active Ingredients

    Active Ingredients

  • Purpose

    Purpose†

    sore gums

    sensitive gums

    pain associated with irritability

    Purpose

    Purpose

    Purpose

  • Keep this and all medicines out of the reach of children.

    Keep this and all medications out of the reach of children. In case of accidental overdose contact a medical professional or a Poison Control Center immediately.

    Keep out reach of children

    Keep out of reach of children

    Keep out of reach of children

  • Questions or comments?

    Questions or comments?

    Call us at 1-800-LUVNCARE M-F 8am-5pm CT

    Questions or comments

    Questions or comments

    Questions or comments

  • Other Information

    Other Information

    Tamper evident - Do not use if tube tip is cut prior to opening.

    Other Information

    Other information

    Other information

  • Directions

    Directions

    • Wash hands before use.

    • Cut open tip of tube on score mark.

    • Use your fingertip or cotton applicator to gently apply a small pea-size amount of Nûby™ Soothing Gel to the affected area every 15 minutes as necessary or as directed by a physician or healthcare provider.

    24016

    24017

    24036

  • Inactive Ingredients

    Inactive ingredients

    Aqua (Purified Water), Potassium Sorbate NF, Sodium Benzoate NF, Sorbic Acid NF, Vegetable Glycerin USP, Xanthan Gum NF.

    Inactive Ingredients

    Inactive ingredients

    Inactive ingredients

  • Uses

    Uses Temporarily relieves sore gums, pain and irritability due to oral discomfort.†

    Uses

    Uses

    Uses

  • WARNINGS

    Warnings

    Consult a physician if • symptoms persist for more than 72 hours or worsen • swelling increases • irritation pain or redness persists or worsens • rash or fever develops

    warnings

    warning

    warnings

  • Principal Display Panel

    PDP

    PDP

    PDP

  • INGREDIENTS AND APPEARANCE
    NUBY SOOTHING GEL 
    soothing gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70797-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT30 [hp_X]  in 15 g
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 15 g
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA12 [hp_X]  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70797-240-011 in 1 BLISTER PACK08/25/2018
    1NDC:70797-240-1515 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:70797-240-021 in 1 BLISTER PACK08/25/2018
    2NDC:70797-240-1515 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3NDC:70797-240-031 in 1 CARTON08/25/2018
    3NDC:70797-240-1515 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/25/2018
    Labeler - Talbot's Pharmaceuticals Family Products, LLC. (078855555)
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