NUBY SOOTHING GEL (SOOTHING GEL) GEL [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]

NUBY SOOTHING GEL (SOOTHING GEL) GEL [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]
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NDC 70797-240-01, 70797-240-02, 70797-240-03, 70797-240-15
Set ID 6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
Category HUMAN OTC DRUG LABEL
Packager Talbot's Pharmaceuticals Family Products, LLC.
Generic Name
Product Class
Product Number
Application Number
  • 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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