Label: 4X MEDICATED GUM CREAM- benzocaine cream
- NDC Code(s): 21130-621-19
- Packager: Albertsons
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 21, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
- cut open tip of tube on score mark
- adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor
- children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
- children under 2 years of age: do not use
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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" anesthetics
Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
4X MEDICATED GUM CREAM
benzocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-621 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 0.25 g in 100 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBIC ACID (UNII: X045WJ989B) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) Product Characteristics Color white (Cloudy white to yellow) Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-621-19 9.4 g in 1 TUBE; Type 0: Not a Combination Product 05/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/07/2021 Labeler - Albertsons (009137209) Registrant - Lornamead Products (119559733) Establishment Name Address ID/FEI Business Operations Lornamead Products 119559733 manufacture(21130-621) , pack(21130-621)

