FDA Label for Jelcaine Sterile
View Indications, Usage & Precautions
Jelcaine Sterile Product Label
The following document was submitted to the FDA by the labeler of this product Brookfield 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.
Active Ingredients
Lidocaine HCl 2% w/v
Purpose
Topical anesthetic
Uses
For temporary relief of pain and itching due to:
- minor cuts
- sunburn
- minor scrapes
- minor burns
- insect bites
- minor skin irritations
Warnings
For external use only.
When Using This Product
- Avoid contact with eyes.
- Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use And Ask A Doctor If
- allergic reaction occurs
- condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
- you experience any redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out Of Reach Of Children
PACKAGE NOT CHILD RESISTANT. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 years of age and older: Apply externally to the affected area not more than 3-4 time daily.
- Children under 2 years of age: Do not use. Consult a doctor.
Other Information
- Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
Inactive Ingredients
hypromellose, methylparaben, propylparaben, sodium hydroxide. May also contain hydrochloric acid to adjust pH.
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