Label: GILTUSS BUCALSEP- benzocaine, menthol, zinc chloride spray
- NDC Code(s): 65852-015-01
- Packager: Dextrum Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 25, 2025
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- Active Ingredients
- Uses
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Warnings
Warnings
Do not use
- IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuosly for 10 minutes. Seek immediate medical attention if pain or irritations persists.
- this product for more than 7 days unless directed by a doctor or a dentist
Methemoglobinemia Warning: use of this product may cause methemoglobinemia, a rare but 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.Stopo 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

- Do not use
- When using this product
- Stop use and ask a doctor if
- If pregnant or breastfeeding
- Keep out of reach of children
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Directions
Directions:
Adults and children 2 years of age and older
- apply to affected area
- gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
- use 4 times daily or as directed by dentist or doctor
- children under 12 years of age should be supervised in the use of the product
Children under 2 years of age: do not use

- Other information
- Inactive Ingredients
- Questions or comments?
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Indication and usage section
Indication and usage section
Adults and children 2 years of age and older
apply to affected area
gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
use 4 times daily or as directed by dentist or doctor
children under 12 years of age should be supervised in the use of the productChildren under 2 years of age: do not use

- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GILTUSS BUCALSEP
benzocaine, menthol, zinc chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65852-015 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC CATION (UNII: 13S1S8SF37) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.12 mg in 100 mL BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6.5 mg in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.1 mg in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLPARABEN (UNII: Z8IX2SC1OH) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65852-015-01 1 in 1 CARTON 07/26/2018 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 07/26/2018 Labeler - Dextrum Laboratories Inc. (007392322)

NDC: 58552-135-01