JELCAINE STERILE- lidocaine hcl jelly usp, 2% jelly

Jelcaine Sterile by

Drug Labeling and Warnings

Jelcaine Sterile by is a Otc medication manufactured, distributed, or labeled by Brookfield Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Jelcaine Sterile (Lidocaine HCl Jelly USP) 2%

INGREDIENTS AND APPEARANCE

JELCAINE STERILE 
lidocaine hcl jelly usp, 2% jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71351-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71351-025-30	30 mL in 1 TUBE; Type 0: Not a Combination Product	09/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/10/2024

Labeler - Brookfield Pharmaceuticals, LLC (080592685)