Label: ORAL ANESTHETIC LIQUID- benzocaine liquid
- NDC Code(s): 79481-0118-9
- Packager: Meijer, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
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
Do not use
- for teething
- in children under 2 years of age
When using this product
- avoid contact with eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a dentist or doctor
Stop use and ask doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
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Directions
Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist
- children under 12 years of age: adult supervision should be given in the use of this product
- children under 2 years of age: do not use
- 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
- Inactive ingredients
- Keep out of reach of children
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAL ANESTHETIC LIQUID
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0118 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 BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color orange (dark orange/red to brown) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0118-9 1 in 1 CARTON 02/05/2024 1 14.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 02/05/2024 Labeler - Meijer, Inc. (006959555) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations HK KOLMAR CANADA, INC 243501959 manufacture(79481-0118) , pack(79481-0118)
