Burn Ease by Front Line Safety BURN EASE gel

Burn Ease by

Drug Labeling and Warnings

Burn Ease by is a Otc medication manufactured, distributed, or labeled by Front Line Safety. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine Hydrochloride USP 2%

Purpose

Analgesic

Use(s)

For the temporary relief of pain associated with Minor burns Sunburn

Warnings

For External Use Only

Do not use

On wounds or damaged skin

In large quantities, particularly over raw surfaces or blistered areas

When using this product

Avoid contact with the eyes

Do not bandage tightly

Stop use and ask a doctor if

Condition worsens

Symptoms persists for more than 7 days

Symptoms clear up and occur again within a few days

Keep out of reach of children

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

Directions

Adults and children 2 year of age and older: Apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other Infomation

Store at controlled room temperature 20º-25ºC (68º-77ºF)

Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosscopolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Oil, Trolamine

Questions?

1-888-900-2920 Monday-Friday, 8AM-4PM PST

Label

INGREDIENTS AND APPEARANCE

BURN EASE 
burn ease gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-6210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
IMIDUREA (UNII: M629807ATL)
TEA TREE OIL (UNII: VIF565UC2G)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-6210-1	900 in 1 CASE	01/08/2024
1		25 in 1 BOX
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/08/2024

Labeler - Front Line Safety (061263699)