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| Product NDC Code | 71888-101 | ||||
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| Drug Name | Benzocaine |
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| Type | Generic | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | Bellus Medical, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzocaine 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.USES : For the temporary relief of discomfort and pain associated with minor burns and skin irritations minor cuts and scrapes itching DIRECTIONS : Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.EthylAlcohol, PEG-8, Purified Water, Carbomer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES: For the temporary relief of discomfort and pain associated with minor burns and skin irritations minor cuts and scrapes itching DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.
Purpose
Information about the drug product’s indications for use.Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Benzocaine Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 SORBIC ACID PHENOXYETHANOL CAPRYLYL GLYCOL ALCOHOL WATER CARBOXYPOLYMETHYLENE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.BLT_4ml_Packet_B_170613
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only. Avoid contact with the eyes. Stop use and ask a doctor if: Skin becomes irritated Condition worsens or symptoms last more than 7 days Symptoms clear up and reoccur within a few days DO NOT USE: in large quantities, particularly over raw surfaces or blistered areas.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API