- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For oral use only
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” anestheticsWhen using this product
- do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
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DOSAGE & ADMINISTRATION
Directions
- to assure formation of long lasting film coating, dry affected area and apply medication undiluted with applicator.
- allow a few seconds for coating to form.
- use up to 4 times daily, or as directed by a dentist or doctor.
- children 12 years of age should be supervised in the use of this product.
- children under 2 years of age: ask a dentist or doctor
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STORAGE AND HANDLING
Other information
- do not purchase if package has been opened
- store at 20 - 25 C (68-77F)
- close cap tightly after use to avoid evaporation
- avoid contact with eyes
- avoid contact with clothing and household furniture surfaces to avoid possible staining
- this is a personal care item, and should be used by one individual only
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INACTIVE INGREDIENT
Inactive ingredients
Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamideacrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, PEG-6, Propylene Glycol, Ricinus Communis (Castor)
Seed Oil, SD Alcohol 38B, Sucralose, Tannic Acid. - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WALGREENS SEVERE ORAL PAIN RELIEVER
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5335 Route of Administration ORAL 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 ALCOHOL (UNII: 3K9958V90M) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) TANNIC ACID (UNII: 28F9E0DJY6) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SUCRALOSE (UNII: 96K6UQ3ZD4) BENZYL ALCOHOL (UNII: LKG8494WBH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) OLETH-10 (UNII: JD797EF70J) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) BENZOIN RESIN (UNII: GK21SBA74R) Product Characteristics Color yellow (orange to reddish orange) Score Shape Size Flavor MINT (Mint Flavor #25797) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5335-51 1 in 1 BLISTER PACK 01/10/2012 1 14.17 g in 1 BOTTLE, WITH APPLICATOR; 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 01/10/2012 Labeler - Walgreens (008965063) Registrant - Lornamead Inc. (078584069) Establishment Name Address ID/FEI Business Operations CSR Cosmetic Solutions 243501959 manufacture(0363-5335)