Lubricaine

Lubricaine
SPL v4
SPL
SPL Set ID 9d7416b1-607d-34e0-e053-2a95a90aa3c3
Route
TOPICAL
Published
Effective Date 2019-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (3.5 g)
Inactive Ingredients
Lactic Acid, Dl- Glycyrrhizinate Dipotassium Stevia Rebaudiuna Leaf Potassium Sorbate Benzyl Alcohol Dehydroacetic Acid Vanilla Aloe Vera Leaf Anhydrous Citric Acid Xanthan Gum Cranberry Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-03
Description

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4% w/w

Uses

For the temporary relief of pain and itching

Section 51945-4

Warnings

For external use only.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am to 5 pm Eastern Time M-F or visit www.esbalabs.com

Directions

Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to affected area no more than 3 to 4 times a day

Active Ingredient

Lidocaine 4% w/w

Other Information
  • Store at room temperature 20-25 oC (68-77 oF)
  • Tamper evident: do not use if foil under cap is damaged or mising.
  • Child-Resistant Cap: push down and turn to open
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Citric Acid, Dehydroacetic Acid, Dipotassium Glycyrrhizinate, Lactic Acid, Natural Flavors, Potassium Sorbate, Purified Water, Stevia Rebaudiana Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Xanthan Gum.

When Using This Product
  • do not use in or near the eye
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not exceed recommended dosage unless directed by a doctor
Stop Use and Ask A Doctor If
  • allergic reaction occurs
  • condition worsens or does not improve within seven days
  • symptoms clear up and return within a few days
  • you notice any unusual effects
Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Structured Label Content

Uses

For the temporary relief of pain and itching

Section 51945-4 (51945-4)

Purpose

Topical Anesthetic

Warnings

For external use only.

Questions

Call toll-free in USA & Canada 800-677-9299 9 am to 5 pm Eastern Time M-F or visit www.esbalabs.com

Directions

Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to affected area no more than 3 to 4 times a day

Active Ingredient

Lidocaine 4% w/w

Other Information
  • Store at room temperature 20-25 oC (68-77 oF)
  • Tamper evident: do not use if foil under cap is damaged or mising.
  • Child-Resistant Cap: push down and turn to open
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Citric Acid, Dehydroacetic Acid, Dipotassium Glycyrrhizinate, Lactic Acid, Natural Flavors, Potassium Sorbate, Purified Water, Stevia Rebaudiana Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Xanthan Gum.

When Using This Product (When using this product)
  • do not use in or near the eye
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not exceed recommended dosage unless directed by a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • allergic reaction occurs
  • condition worsens or does not improve within seven days
  • symptoms clear up and return within a few days
  • you notice any unusual effects
Keep Out of the Reach of Children (Keep out of the reach of children)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:36.533025 · Updated: 2026-03-14T23:03:46.018464