Jelcaine Sterile

Jelcaine Sterile
SPL v2
SPL
SPL Set ID 1a39d1de-7aa2-3068-e063-6394a90aed85
Route
TOPICAL
Published
Effective Date 2024-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Hydrochloric Acid Methylparaben Propylparaben Sodium Hydroxide Hypromelloses

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-10
Description

Lidocaine HCl 2% w/v

Purpose

Topical anesthetic

Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCl 2% w/v

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.

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.
Active Ingredients

Lidocaine HCl 2% w/v

Inactive Ingredients

hypromellose, methylparaben, propylparaben, sodium hydroxide. May also contain hydrochloric acid to adjust pH.

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.

Jelcaine Sterile (lidocaine Hcl Jelly Usp) 2%

Structured Label Content

Uses

For temporary relief of pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations
Purpose

Topical anesthetic

Warnings

For external use only.

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 (Other information)
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
Active Ingredients

Lidocaine HCl 2% w/v

Inactive Ingredients (Inactive ingredients)

hypromellose, methylparaben, propylparaben, sodium hydroxide. May also contain hydrochloric acid to adjust pH.

When Using This Product (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 (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 (Keep out of reach of children)

PACKAGE NOT CHILD RESISTANT. If swallowed, get medical help or contact a Poison Control Center right away.

Jelcaine Sterile (lidocaine Hcl Jelly Usp) 2% (Jelcaine Sterile (Lidocaine HCl Jelly USP) 2%)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:33.035629 · Updated: 2026-03-14T23:13:32.363247