Otc - Active Ingredient
- Arnica, radix 30X HPUS 3.33 %
- Calcarea phosphorica 12XHPUS 3.33 %
- Chamomilla 12X HPUS 3.33 %
Nuby Soothing Gel
FDA Label NDC 85182-240
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Raffini Imports & Exports Co Ltd for the product Nuby Soothing Gel (NDC 85182-240). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, warnings, instructions for use, otc - keep out of reach of children, otc - questions, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
- Aqua (Purified Water)
- Potassium Sorbate NF
- Sodium Benzoate NF
- Sorbic Acid NF
- Vegetable Glycerin USP
- Xantham Gum NF
Otc - Purpose
Temporarily relieves sore gums, pain, and irritability due to oral discomfort.
Warnings
Counsult a Physician if
- symptoms persist for more than 72 hours or worsen
- irritation, pain, or redness persits or worsen
- rash or fever develops
- swelling increases
Instructions For Use
- Wash hands before use
- Cut open tip of tube on score mark
- Use your fingertip or cotton applicator to gently apply a small pea-sized maount of Dr. Talbot's Soothing Gel to the affected area 15 miniutes as neccassary or as directed by a physician or health provider
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of the reach of children.
In case of accidental overdose, contact a medical professional or a Poison Control immidiately.
Otc - Questions
Call us at 1-855-366-7755 (U.S.A. only) M-F 8 am - 5 pm CT
Other Safety Information
Tamper evident - Do not use if tube tip is cut prior to opening
Package Label.Principal Display Panel
DR. Talbot's
Soothing Gel
Naturally Inspired
Soothes sore Gums
with Chamomile
Benzocaine/Belladonna free
* Please review the disclaimer below.
