Label: GUMSOL- benzocaine, zinc chloride spray
- NDC Code(s): 52083-714-01
- Packager: Kramer Novis
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 26, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in 30 mL)
- Purposes
- 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
- Packaging
-
INGREDIENTS AND APPEARANCE
GUMSOL
benzocaine, zinc chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-714 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 1.5 g in 30 mL ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.03 g in 30 mL Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-714-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/28/2014 Labeler - Kramer Novis (090158395)
