FDA Label for Sheffield Lidocaine

View Indications, Usage & Precautions

Sheffield Lidocaine Product Label

The following document was submitted to the FDA by the labeler of this product Sheffield Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts


Active Ingredient



Lidocaine  4%


Purpose



Topical anesthetic


Uses



  • Temporarily relieves minor pain

Warnings



For external use only


Do Not Use



  • on large areas of the body or on cut,irritated or swollen skin
  • on puncture wounds
  • for more than one week without consultanting a doctor

When Using This Product



use only as directed. read and follow all directions and warnings on this carton.

do notallow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use.


Stop Use And Ask A Doctor If



  • condition worsens
  • symptons persist for more than 7 days or clear up and occur again within a few days.
  • If pregnant or breast feeding, ask a health professional before use.

Keep This And All Drugs Out Of The Reach Of Children And Pets.



If swallowed, get medical help or contact Poison Control Center right away.


Directions



  • Adults and children over 12 years: 
  • apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period
  • Children under 12 years  or younger: ask a doctor

Other Information



  • Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients



Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Polysorbate 80,  Propylene Glycol, Tocopheryl Acetate, Trolamine, Water (purified)


Questions?(




Principal Panel-Tube



Sheffield  NDC 11527-191-30

4% Lidocaine

Topical Anesthetic Cream

NET WT. 30g (1.06 oz)


Principal Panel - Carton



Sheffield    NDC 11527-191-30

4% Lidocaine

Topcial Anestheic Cream 

NET WT. 30g (1.06 oz)


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