NDC | 63868-953-11 |
Set ID | dbde8e7f-85d8-4083-b01a-3a7e410a7747 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Marketing Association Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- ACTIVE INGREDIENT
- PURPOSE
-
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 your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
- DO NOT USE
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions Adults and children 2 years of age and older.
Remove cap and cut tip of tube. Apply a small amount of
product to the cavity and around gum surrounding the teeth.
Use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age. Should be supervised in the use of this product. Children under 2 years of age. Do not use. - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-953 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PEPPERMINT OIL (UNII: AV092KU4JH) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-953-11 1 in 1 CARTON 05/31/2013 1 11.76 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 05/31/2013 Labeler - Chain Drug Marketing Association Inc (011920774)