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NDC 52083-0714-01 Gumsol 1.5; .03 g/30mL; g/30mL Details
Gumsol 1.5; .03 g/30mL; g/30mL
Gumsol is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is BENZOCAINE; ZINC CHLORIDE.
Product Information
| NDC | 52083-0714 |
|---|---|
| Product ID | 52083-714_9f4c663e-aa3c-4190-83c7-61ec6f0a4eb7 |
| Associated GPIs | 88359902090920 |
| GCN Sequence Number | 058909 |
| GCN Sequence Number Description | zinc chloride/benzocaine SPRAY 0.1 %-5 % MUCOUS MEM |
| HIC3 | D1D |
| HIC3 Description | DENTAL AIDS AND PREPARATIONS |
| GCN | 24438 |
| HICL Sequence Number | 032817 |
| HICL Sequence Number Description | ZINC CHLORIDE/BENZOCAINE |
| Brand/Generic | Brand |
| Proprietary Name | Gumsol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzocaine, Zinc Chloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | ORAL |
| Active Ingredient Strength | 1.5; .03 |
| Active Ingredient Units | g/30mL; g/30mL |
| Substance Name | BENZOCAINE; ZINC CHLORIDE |
| Labeler Name | Kramer Novis |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52083-0714-01 (52083071401)
| NDC Package Code | 52083-714-01 |
|---|---|
| Billing NDC | 52083071401 |
| Package | 30 mL in 1 BOTTLE (52083-714-01) |
| Marketing Start Date | 2014-02-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf Details
Use
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you, or a child in your care develops:
• Pale gray, or blue colored skin (cyanosis)
• Headache • Rapid heart rate • Shortness of breath
• Dizziness or lightheadedness • Fatigue or lack of energy
Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetic. If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly
Do not use(unless directed by a doctor): • more than directed • for more than 7 days • in children under 2 years of age • for teething.
Stop use and see a doctor promptly if: • sore mouth symptoms do not improve in 7 days
• irritation, pain or redness persist or worsen
• swelling, rash or fever develops.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Other information:
Inactive ingredients
Questions or comments?
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| GUMSOL
benzocaine, zinc chloride spray |
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| Labeler - Kramer Novis (090158395) |