Label: WALGREENS MAXIMUM STRENGTH- benzocaine paste, dentifrice
- NDC Code(s): 0363-5337-19
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 January 11, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
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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 (080046418) Establishment Name Address ID/FEI Business Operations Lornamead Inc. 080046418 manufacture(0363-5337)
