FDA.reportPublic FDA data

Nuby Soothing Gel

Manufacturer
Talbot's Pharmaceuticals Family Products, LLC.
Effective date
2018-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:24

Label at a glance#

ProductNuby Soothing Gel
Active ingredientARNICA MONTANA ROOT, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA
Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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 IngredientsActive Ingredients

Active IngredientsActive Ingredients

Active IngredientsActive Ingredients

Purpose

OTC - PURPOSE SECTION

Purpose†

sore gums

sensitive gums

pain associated with irritability

PurposePurpose

PurposePurpose

PurposePurpose

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

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 professional or a Poison Control Center immediately.

Keep out reach of childrenKeep out reach of children

Keep out of reach of childrenKeep out of reach of children

Keep out of reach of childrenKeep out of reach of children

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?

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

Questions or commentsQuestions or comments

Questions or commentsQuestions or comments

Questions or commentsQuestions or comments

Other Information

OTHER SAFETY INFORMATION

Other Information

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

Other InformationOther Information

Other informationOther information

Other informationOther information

Directions

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 Nûby™ Soothing Gel to the affected area every 15 minutes as necessary or as directed by a physician or healthcare provider.

2401624016

2401724017

2403624036

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

Inactive IngredientsInactive Ingredients

Inactive ingredientsInactive ingredients

Inactive ingredientsInactive ingredients

Uses

INDICATIONS & USAGE SECTION

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

UsesUses

UsesUses

UsesUses

WARNINGS SECTION

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

warningswarnings

warningwarning

warningswarnings

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

PDPPDP

PDPPDP

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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70797-240-012024-01-30C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-022024-01-30C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-032024-01-30C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-012023-11-09C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-022023-11-09C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-032023-11-09C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-012023-07-28C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-022023-07-28C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
70797-240-032023-07-28C16284748780-10191ceaa-6753-198a-e063-dbdaa90aec3e6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70797-240-01Nuby Soothing Gel1 in 1 BLISTER PACKGEL11
70797-240-02Nuby Soothing Gel1 in 1 BLISTER PACKGEL11
70797-240-03Nuby Soothing Gel1 in 1 CARTONGEL11
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, 4 package rows20180825_6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0.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, 70797-240-01, 70797-240-02, 70797-240-03

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
GLYCERINPDC6A3C0OXIACT
ARNICA MONTANA ROOTMUE8Y11327ACTIB
XANTHAN GUMTTV12P4NEEIACT
SORBIC ACIDX045WJ989BIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
MATRICARIA RECUTITAG0R4UBI2ZZACTIB

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
6e8cd19e-5a00-d0fa-e053-2a91aa0a04c06e8cd19e-59ff-d0fa-e053-2a91aa0a04c02018-06-13WarningsExact identifier
spl id: 6e8cd19e-5a00-d0fa-e053-2a91aa0a04c0
spl set id: 6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0

Reported adverse events (FAERS/openFDA)#

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