NUBY SOOTHING GEL- soothing gel gel 
Talbot's Pharmaceuticals Family Products, LLC.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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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

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

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)

Revised: 6/2018
Document Id: 6e8cd19e-5a00-d0fa-e053-2a91aa0a04c0
Set id: 6e8cd19e-59ff-d0fa-e053-2a91aa0a04c0
Version: 1
Effective Time: 20180613
 
Talbot's Pharmaceuticals Family Products, LLC.