Label: THERACARE MAXIMUM STRENGTH ORAL PAIN RELIEF SEVERE- benzocaine 20%, benzalkonium chloride 1% gel
- NDC Code(s): 71101-201-01
- Packager: Veridian Healthcare
- Category: HUMAN OTC DRUG LABEL
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 October 20, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- 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
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Adults and children 2 years of age and over - Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
- Children under 12 years of age - Should be supervised in the use of this product
- Children under 2 years of age - Ask a physician or healthcare provider
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Other information
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
- do not use if tube seal under cap is broken
- store at 20-25C (68-77F)
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THERACARE MAXIMUM STRENGTH ORAL PAIN RELIEF SEVERE
benzocaine 20%, benzalkonium chloride 1% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-201-01 1 in 1 CARTON 02/01/2022 1 9.35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/01/2022 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations ANICARE PHARMACEUTICALS PRIVATE LIMITED 916837425 manufacture(71101-201)
