Label: ANESTHETIC LOZENGES HONEY LIME FLAVORS- benzocaine,menthol lozenge
-
Contains inactivated NDC Code(s)
NDC Code(s): 83348-002-01 - Packager: PRASON FOODS
- 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 May 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
Warning
Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduced 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, grey, or blue colored skin (Cyanosis)
- Headache
- Rapid heart ache
- Shortness of breath
- Dizziness or light headedness
- Fatigue or lack of energy
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens, see your dentist or doctor promptly.
Do not use
- For teething
- In children under 5 years of age
Stop use and ask doctor if
- Sore mouth symptoms do not improve in 7 days.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.Allergy alert : Do not use this product if you have a history of allergy to local anesthetic such as procaine, butacaine, benzocaine, or other "caine" anesthetics
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
- Product label
-
INGREDIENTS AND APPEARANCE
ANESTHETIC LOZENGES HONEY LIME FLAVORS
benzocaine,menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83348-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 15 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.6 mg Inactive Ingredients Ingredient Name Strength DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) SUCROSE (UNII: C151H8M554) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) TARTARIC ACID (UNII: W4888I119H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score no score Shape ROUND Size 18mm Flavor HONEY (Honey and Lime) Imprint Code NO Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83348-002-01 10 in 1 CARTON 04/15/2023 1 9 in 1 BLISTER PACK; 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 04/15/2023 Labeler - PRASON FOODS (861707089) Establishment Name Address ID/FEI Business Operations PRASON FOODS 861707089 manufacture(83348-002)