NUBY SOOTHING GEL- soothing gel gel

Nuby Soothing Gel by

Drug Labeling and Warnings

Nuby Soothing Gel by is a Homeopathic medication manufactured, distributed, or labeled by NINGBO RAFFINI IMPORTS & EXPORTS CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Arnica, radix 30X HPUS 3.33 %
• Calcarea phosphorica 12XHPUS 3.33 %
• Chamomilla 12X HPUS 3.33 %

INACTIVE INGREDIENT

• Aqua (Purified Water)
• Potassium Sorbate NF
• Sodium Benzoate NF
• Sorbic Acid NF
• Vegetable Glycerin USP
• Xantham Gum NF

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

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.

QUESTIONS

Call us at 1-855-366-7755 (U.S.A. only) M-F 8 am - 5 pm CT

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

DR. Talbot's

Soothing Gel

Naturally Inspired

Soothes sore Gums

with Chamomile

Benzocaine/Belladonna free

INGREDIENTS AND APPEARANCE

NUBY SOOTHING GEL 
soothing gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85182-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X]  in 15 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	12 [hp_X]  in 15 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	30 [hp_X]  in 15 g

Inactive Ingredients
Ingredient Name	Strength
SORBIC ACID (UNII: X045WJ989B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85182-240-04	1 in 1 BLISTER PACK	01/21/2025
1	NDC: 85182-240-15	15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/21/2025

Labeler - NINGBO RAFFINI IMPORTS & EXPORTS CO LTD (528178863)