Label: ANESTHETIC- benzocaine gel
- NDC Code(s): 55670-810-01
- Packager: Moore Medical LLC
- 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 October 25, 2022
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 (in each gram)
- Purpose
- Uses
-
Warnings
For oral use only.
Do not exceed recommended dosage.
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before.
Stop use and seek medical attention if you or a child in your care develops:
- pale, gray or blue colored skin (cyanosis)
- rapid heart rate
- dizziness or lightheadedness
- headache
- shortness of breath
- 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. If a skin reaction occrs, stop use and seek medical help right away.
Do not use
- for teething - any teething related indication will not be ab appropriate use of this product
- in children under 2 years of age
- for more than 7 days unless directed by a doctor
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments?
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INGREDIENTS AND APPEARANCE
ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55670-810 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) PEPPERMINT OIL (UNII: AV092KU4JH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55670-810-01 75 in 1 BOX 07/12/2012 05/31/2024 1 0.75 g in 1 PACKET; 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 07/12/2012 05/31/2024 Labeler - Moore Medical LLC (051420107) Registrant - Unifirts First Aid Corporation (832947092)