Advanced Seal®

Advanced Seal®
SPL v2
SPL
SPL Set ID 7ac95325-e6e9-4c56-9315-876c00af7c98
Route
TOPICAL
Published
Effective Date 2020-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (20 mg)
Inactive Ingredients
Water Alcohol Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Hydroxyethyl Cellulose (2000 Mpa.s At 1%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-10

Description

Lidocaine 2%

Purpose

Topical anesthetic


Medication Information

Warnings and Precautions

Warnings: For external use only. Avoid contact with eyes. Do not ingest. Contact a doctor if pregnant, breastfeeding, or if condition worsens.

Indications and Usage

Uses: For the temporary relief of pain and itch in minor cuts, burns, scrapes, skin irritations, insect bites and sunburn

Purpose

Topical anesthetic

Dosage and Administration

Directions: Adults & children age 2 & older. Shake well then apply spray. DO NOT RUB IN. Allow a clear, thin film to set. Apply up to 3x a day for 7 days. Children under 2 years of age consult a physician

Description

Lidocaine 2%

Section 42229-5

Soothe, Seal & ProtectTM

Lidocaine + breathable, elastic barrier

Seals in hydration for Advanced Healing

Cuts • Burns • Rashes • Irritation & More

KeriCureMedical.com

KeriCure Inc. Baltimore, MD 21229

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose

Purpose:

Topical anesthetic

Packaging

Drug Facts

Active Ingredients:

Lidocaine 2%


Structured Label Content

Indications and Usage (34067-9)

Uses: For the temporary relief of pain and itch in minor cuts, burns, scrapes, skin irritations, insect bites and sunburn

Dosage and Administration (34068-7)

Directions: Adults & children age 2 & older. Shake well then apply spray. DO NOT RUB IN. Allow a clear, thin film to set. Apply up to 3x a day for 7 days. Children under 2 years of age consult a physician

Warnings and Precautions (34071-1)

Warnings: For external use only. Avoid contact with eyes. Do not ingest. Contact a doctor if pregnant, breastfeeding, or if condition worsens.

Section 42229-5 (42229-5)

Soothe, Seal & ProtectTM

Lidocaine + breathable, elastic barrier

Seals in hydration for Advanced Healing

Cuts • Burns • Rashes • Irritation & More

KeriCureMedical.com

KeriCure Inc. Baltimore, MD 21229

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose

Purpose:

Topical anesthetic

Packaging

Drug Facts (DRUG FACTS)

Active Ingredients:

Lidocaine 2%


Advanced Ingredient Data


Raw Label Data

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