The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Longwell Baby Products Co Ltd for the product Nuby Soothing Gel (NDC 71240-240). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, keep this and all medicines out of the reach of children., questions or comments?, other information, directions, inactive ingredients, uses, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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Purpose†
sore gums
sensitive gums
pain associated with irritability
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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.
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Questions or comments?
Call us at 1-800-LUVNCARE M-F 8am-5pm CT
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Other Information
Tamper evident - Do not use if tube tip is cut prior to opening.
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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.
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Inactive ingredients
Aqua (Purified Water), Potassium Sorbate NF, Sodium Benzoate NF, Sorbic Acid NF, Vegetable Glycerin USP, Xanthan Gum NF.
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Uses Temporarily relieves sore gums, pain and irritability due to oral discomfort.†
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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
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* Please review the disclaimer below.
