ADVANCED SEAL BARRIER PLUS PAIN RELIEF- lidocaine spray
Kericure Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ADVANCED SEAL® BARRIER + PAIN RELIEF

DRUG FACTS

Active Ingredients:

Lidocaine 2%

Purpose:

Topical anesthetic

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

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.

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 Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose

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

image description

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/10/2020

Labeler - Kericure Inc. (966638681)