ADVANCED SEAL BARRIER PLUS PAIN RELIEF- lidocaine spray

Advanced Seal Barrier plus Pain Relief by

Drug Labeling and Warnings

Advanced Seal Barrier plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Kericure Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients:

Lidocaine 2%

Purpose:

Topical anesthetic

INDICATIONS & USAGE

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

WARNINGS

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

Keep out of reach of children.

DOSAGE & 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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

ADVANCED SEAL BARRIER PLUS PAIN RELIEF 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78280-703
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78280-703-01	25 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/10/2020

Labeler - Kericure Inc. (966638681)