![CVS TOOTH AND GUM PAIN RELIEF CUSHIONS (BENZOCAINE) STRIP [CVS PHARMACY]](https://medic.hrt.org//dailymed/images/81696275-fea3-f0d8-e053-2991aa0a4c4c/CVS_ToothCushions_Carton_F8015370.jpg)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 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
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DOSAGE & ADMINISTRATION
Directions
- Carefully remove gel cushion from blister. Gently mold iwth fingers until soft. Apply to affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth.
- Adults and children 12 years of age and older: use up to 3 times daily or as directed by dentist or doctor.
- Children under 12 years of age: ask a dentist or doctor
- Children under 2 years of age: do not use
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STORAGE AND HANDLING
Other information
Do not use if blister card is broken. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously. These toothache cushions are designed to completely dissolve in place.
Store at room temperature 15-30°C (59-86°F)
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
CVS Health™
Moldable Gel Cushions
Medicated
Tooth & Gum Pain Relief Cushions
BENZOCAINE 10%, ORAL PAIN RELIEVER
For Immediate Pain Relief
- Soothes & comforts
- Long lasting - stays in place twice as long as the leading gel*
- Great for use with braces
8 GEL CUSHIONS, 0.5 g EACH
*Based on lab dissolution study.
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INGREDIENTS AND APPEARANCE
CVS TOOTH AND GUM PAIN RELIEF CUSHIONS
benzocaine stripProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-381 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) MENTHOL (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-381-09 8 in 1 CARTON 02/08/2019 1 0.5 g in 1 BLISTER PACK; 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 02/08/2019 09/29/2022 Labeler - CVS Pharmacy (062312574) Registrant - Lornamead Inc. (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(69842-381)