Label: WALGREENS SEVERE ORAL PAIN RELIEVER- benzocaine liquid
- NDC Code(s): 0363-5335-51
- 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.
Updated October 20, 2021
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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” anesthetics
When 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.
DOSAGE & ADMINISTRATION
- 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
STORAGE AND HANDLING
- 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
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
INGREDIENTS AND APPEARANCE
WALGREENS SEVERE ORAL PAIN RELIEVER
Product 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)