{"active_ingredient":["ACTIVE INGREDIENT Anbesol Regular Strength Cool Mint Liquid and Gel Benzocaine 10% Anbesol Maximum Strength Liquid and Gel Benzocaine 20%","Anbesol Regular Strength Cool Mint Liquid and Gel Benzocaine 10%","Anbesol Maximum Strength Liquid and Gel Benzocaine 20%"],"do_not_use":["Do not use • for teething • in children under age 2"],"dosage_and_administration":["DIRECTIONS Anbesol Regular Strength Cool Mint and Maximum Strength Liquid • adults and children 2 years of age and older: • wipe liquid on with cotton, or cotton swab, or fingertip • apply to the affected area up to 4 times daily or as directed by a doctor/dentist • children under 12 years of age: adult supervision should be given in the use of this product • children under 2 years of age: do not use Anbesol Regular Strength Cool Mint and Maximum Strength Gel • to open tube, cut tip of the tube on score mark with scissors • adults and children 2 years of age and older: apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist • children under 12 years of age: adult supervision should be given in the use of this product • children under 2 years of age: do not use • for denture irritation: • apply thin layer to the affected area • do not reinsert dental work until irritation/pain is relieved • rinse mouth well before reinserting"],"effective_time":"20220106","id":"5c1f09bb-d5f7-4c27-b001-3fc7bab8a2ba","inactive_ingredient":["INACTIVE INGREDIENTS Anbesol Regular Strength Cool Mint Liquid benzyl alcohol, D&C red no. 33, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, methylparaben, natural and artificial flavors, polyethylene glycol, propylene glycol, saccharin Anbesol Regular Strength Cool Mint Gel benzyl alcohol, carbomer 934P, D&C red no. 33, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylene glycol, saccharin Anbesol Maximum Strength Liquid benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin Anbesol Maximum Strength Gel benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin","Anbesol Regular Strength Cool Mint Liquid benzyl alcohol, D&C red no. 33, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, methylparaben, natural and artificial flavors, polyethylene glycol, propylene glycol, saccharin","Anbesol Regular Strength Cool Mint Gel benzyl alcohol, carbomer 934P, D&C red no. 33, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylene glycol, saccharin","Anbesol Maximum Strength Liquid benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin","Anbesol Maximum Strength Gel benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin"],"indications_and_usage":["USES • temporarily relieves pain associated with the following mouth and gum irritations: • toothache • sore gums • canker sores • braces • minor dental procedures • dentures"],"keep_out_of_reach_of_children":["Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 10% cool mint gel See new warnings information Anbesol ® Oral Anesthetic/Benzocaine 10% REGULAR STRENGTH DOCTOR RECOMMENDED Instant Pain Relief • Toothaches • Gum Pain • Canker Sores • Denture Pain NET WT 0.33 OZ (9 g) Safety Sealed Tube: Do Not Use if tube tip is cut prior to opening. PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 10%","PRINCIPAL DISPLAY PANEL - 12 ml Bottle Blister Pack - 10% cool mint liquid See new warnings information Anbesol ® Oral Anesthetic/Benzocaine 10% REGULAR STRENGTH DOCTOR RECOMMENDED Instant Pain Relief • Toothaches • Gum Pain • Canker Sores • Denture Pain NET WT 0.41 FL OZ (12 ml) Do Not Use if plastic blister or backing material is broken or if backing material is separated from the plastic. Principal Display Panel - 12 ml Bottle Blister Pack - 10%","PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 20% gel See new warnings information Anbesol ® Oral Anesthetic/Benzocaine 20% MAXIMUM STRENGTH DOCTOR RECOMMENDED Instant Pain Relief • Toothaches • Gum Pain • Canker Sores • Denture Pain NET WT 0.33 OZ (9 g) Safety Sealed Tube: Do Not Use if tube tip is cut prior to opening. PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack - 20%","PRINCIPAL DISPLAY PANEL - 12 ml Bottle Blister Pack - 20% liquid See new warnings information Anbesol ® Oral Anesthetic/Benzocaine 20% MAXIMUM STRENGTH DOCTOR RECOMMENDED Instant Pain Relief • Toothaches • Gum Pain • Canker Sores • Denture Pain NET WT 0.41 FL OZ (12 ml) Do Not Use if plastic blister or backing material is broken or if backing material is separated from the plastic. Principal Display Panel - 12 ml Bottle Blister Pack - 20%"],"purpose":["PURPOSE Oral Anesthetic"],"set_id":"924a4421-cd8b-8e5c-d7e6-d022fabb694f","spl_product_data_elements":["ANBESOL REGULAR STRENGTH benzocaine BENZOCAINE BENZOCAINE BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SACCHARIN ANBESOL REGULAR STRENGTH benzocaine BENZOCAINE BENZOCAINE BENZYL ALCOHOL D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SACCHARIN ANBESOL MAXIMUM STRENGTH benzocaine BENZOCAINE BENZOCAINE BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL SACCHARIN ANBESOL MAXIMUM STRENGTH benzocaine BENZOCAINE BENZOCAINE BENZYL ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL SACCHARIN"],"spl_unclassified_section":["PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available."],"stop_use":["Stop use and ask a doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash, or fever develops"],"storage_and_handling":["OTHER INFORMATION Anbesol Regular Strength Cool Mint Liquid and Gel and Anbesol Maximum Strength Liquid Store at 20-25°C (68-77°F) Anbesol Maximum Strength Gel Store at 20-25°C (68-77°F). Do not refrigerate."],"version":"8","warnings":["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 the 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 • for teething • in children under age 2 When using this product • avoid contact with the eyes • do not exceed recommended dosage • do not use for more than 7 days unless directed by a doctor/dentist Stop use and ask a doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash, or fever develops Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product • avoid contact with the eyes • do not exceed recommended dosage • do not use for more than 7 days unless directed by a doctor/dentist"]}