FDA.reportPublic FDA data

Nuby Soothing Gel

Manufacturer
Talbot's Pharmaceuticals Family Products, LLC.
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:31:31

Label at a glance#

ProductNuby Soothing Gel
Active ingredientMATRICARIA RECUTITA, ARNICA MONTANA ROOT, TRIBASIC CALCIUM PHOSPHATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

  • Active IngredientsActive IngredientsArnica Montana, radix 30X HPUS 3.33%
  • Calcarea Phosphorica 12 X HPUS 3.33%
  • Chamomilla 12X HPUS 3.33%

INACTIVE INGREDIENT SECTION

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

Inactive IngredientInactive Ingredient

WARNINGS SECTION

Counsult a Physician if

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

WarninsWarnins

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children

​​in case of accidental overdose, contact a medical perffessional or a Poision Control Center immidiately.

Keep out of the reach of childrenKeep out of the reach of children

OTC - PURPOSE SECTION

Purpose

  • soregums
  • sensitive gums
  • pain ssociated with irritability

Purpose SectionPurpose Section

DOSAGE & ADMINISTRATION SECTION

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 Dr. Talbot's Soothing gel to the affected area every 15 minitues as neccessary or as directed by a physician or healthcare provider

Dosage and Admin Section jpgDosage and Admin Section jpg

OTHER SAFETY INFORMATION

Other information

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

Other Safety InformationOther Safety Information

OTC - QUESTIONS SECTION

Questions & comments?

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

QUESTIONS & COMMENTS. JPGQUESTIONS & COMMENTS. JPG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70797-240-01 Bonus!!

SAFE TO SWALLOW Gum-eez-teether

Dr Talbot's

Soothing Gel 0m+

Naturally

Inspired

Soothes

sore gums

With

Chamomile

Benzocaine

/Belledonna

free

Principal Display PanelPrincipal Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70797-240-04Nuby Soothing Gel1 in 1 BLISTER PACKGEL11
70797-240-15Nuby Soothing Gel15 g in 1 TUBEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-240NUBY SOOTHING GEL (SOOTHING GEL) GEL [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]1Legacy NDC, 2 package rows20250124_2c2b328d-8283-d28d-e063-6294a90a5bd9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70797-24070797-240-15, 70797-240-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
SORBIC ACIDX045WJ989BIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
XANTHAN GUMTTV12P4NEEIACT
ARNICA MONTANA ROOTMUE8Y11327ACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2c2b328d-8284-d28d-e063-6294a90a5bd92c2b328d-8283-d28d-e063-6294a90a5bd92025-01-20WarningsExact identifier
spl id: 2c2b328d-8284-d28d-e063-6294a90a5bd9
spl set id: 2c2b328d-8283-d28d-e063-6294a90a5bd9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.