- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
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.
When using this product
- avoid contact with eyes
- do not use more than directed
- do not use for more than 7 days unless told to do so by a dentist or doctor.
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DOSAGE & ADMINISTRATION
Directions
- cut open tip of tube on score mark
- adults and children 2 years of age and older: apply to the affected area 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: ask a dentist or doctor
- for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WALGREENS MAXIMUM STRENGTH
benzocaine paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5337 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 MENTHOL (UNII: L7T10EIP3A) PETROLATUM (UNII: 4T6H12BN9U) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SACCHARIN (UNII: FST467XS7D) METHYL SALICYLATE (UNII: LAV5U5022Y) PECTIN (UNII: 89NA02M4RX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) Product Characteristics Color Score Shape Size Flavor WINTERGREEN (L Menthol) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5337-19 1 in 1 CARTON 08/01/2013 1 12 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 08/01/2013 Labeler - Walgreens (008965063) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(0363-5337)