PS-3866 BURN EASE, 0.9G gel

PS-3866 Burn Ease, 0.9g by

Drug Labeling and Warnings

PS-3866 Burn Ease, 0.9g by is a Otc medication manufactured, distributed, or labeled by ProStat First Aid LLC, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine Hydrochloride 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 persist 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 years 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 Information

Store at room temperature

Inactive Ingredients

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

Questions?

1-888-900-2920 8AM - 4PM PST

Label

PS-3866 Burn Ease, 0.9g

INGREDIENTS AND APPEARANCE

PS-3866 BURN EASE, 0.9G 
ps-3866 burn ease, 0.9g gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-3866
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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
IMIDUREA (UNII: M629807ATL)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-3866-1	1000 in 1 CARTON	07/31/2023
1		10 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 not final	part348	07/31/2023

Labeler - ProStat First Aid LLC (061263699)

Registrant - Dynarex Corporation (008124539)