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| Product NDC Code | 11527-062 | ||||
|---|---|---|---|---|---|
| Drug Name | Sheffield pain relief |
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| Type | Brand | ||||
| 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 | ORAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 238910 | ||||
| Application Number | M022 | ||||
| Labeler Name | Sheffield Pharmaceuticals 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.Active Ingredient 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.Directions do not use tube if it is cut prior to opening cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel apply to affected area up to four times daily or as directed by a dentist or physician Adults and children 2 years of age and older: Apply to affected area Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Flavor, PEG 540, PEG 6, PEG 75, PEG 8, Sodium Saccharin, 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 temporary relief of occasional minor irritation, pain and sore mouth
Purpose
Information about the drug product’s indications for use.Purpose Oral Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Sheffield Pain Relief BENZOCAINE BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 1500 POLYETHYLENE GLYCOL 3350 Saccharin Sodium Sorbic Acid SPEARMINT
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.Principal Display Panel – 0.33oz Carton Label Sheffield Pharmaceuticals NDC 11527-062-47 Oral Pain Relief Maxium Strength GEL Fast Toothache Pain Reliever 20% Benzocaine Topical Gel NET WT. 0.33 OZ (9.35g) Made in the USA Principal Display Panel – 0.33oz Carton Label
Principal Display Panel – 0.33oz Tube Label Sheffield Pharmaceuticals NDC 11527-062-47 Oral Pain Relief Maxium Strength GEL Fast Toothache Pain Reliever 20 % Benzocaine Topical Gel Made in the USA NET WT. 0.33 OZ (9.35g) Principal Display Panel – 0.33oz Tube Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information store at a controlled room temperature 59°-86°F (15°-30°C)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if swelling, rash or fever develops irritation, pain, or redness persists or worsens
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.Warnings 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 more than directed for more than 7 days unless told to do so by a dentist or doctor Stop use and ask a doctor if swelling, rash or fever develops irritation, pain, or redness persists or worsens Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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