Label: RITE AID PROFESSIONAL STRENGTH- benzocaine liquid
- NDC Code(s): 11822-5340-1, 11822-5340-8
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Use
-
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” 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. -
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 - DOSAGE & ADMINISTRATION
-
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 - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RITE AID PROFESSIONAL STRENGTH
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-5340 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 MENTHOL (UNII: L7T10EIP3A) ALCOHOL (UNII: 3K9958V90M) ETHYLCELLULOSES (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 300 (UNII: 5655G9Y8AQ) 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:11822-5340-8 1 in 1 BLISTER PACK 01/11/2023 1 NDC:11822-5340-1 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 final part333B 01/01/2014 Labeler - Rite Aid (014578892) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations CSR Cosmetic Solutions 243501959 manufacture(11822-5340) , pack(11822-5340)