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 Longwell Baby Products Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Purpose

Purpose†

sore gums

sensitive gums

pain associated with irritability

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.

Questions or comments?

Questions or comments?

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

Other Information

Other Information

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

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.

Inactive Ingredients

Inactive ingredients

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

Uses

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

WARNINGS

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

NUBY SOOTHING GEL 
soothing gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71240-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X]  in 15 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71240-240-02	1 in 1 BLISTER PACK	08/25/2018
1	NDC: 71240-240-15	15 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2	NDC: 71240-240-03	1 in 1 CARTON	08/25/2018
2	NDC: 71240-240-15	15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71240-240-01	1 in 1 BLISTER PACK	08/25/2018
3	NDC: 71240-240-15	15 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/25/2018

Labeler - Ningbo Longwell Baby Products Co Ltd (527868252)