FIRST AID BURN- lidocaine hydrochloride,benzalkonium chloride cream

FIRST AID BURN by

Drug Labeling and Warnings

FIRST AID BURN by is a Otc medication manufactured, distributed, or labeled by Epic Medical Supply Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

Topical Analgesic

Topical Antiseptic

Uses

For temporary relief of pain and itching associated with:

• Sunburn
• Minor burns,
• Insect bites,
• Minor skin irritation,
• Cuts
• Scrapes

Warnings

For external use only

Do not use

• in the eyes 
• over large areas of the body or on deep puncture wounds, animal bites, or serious burns 
• in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if 

• the condition gets worse 
• condition clears up and recurs within a few days 
• condition persists for more than 7 days

• If pregnant or breast feeding, ask a health care professional before use.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

KEEP OUT OF REACH OF CHILDREN

Directions

• Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage
• Children under 2 years: consult a doctor

Other information

• Store at room temperature 
• tamper evident sealed packets 
• do not use any opened or torn packets

Inactive ingredients

Butylated Hydroxytoluene, Cetostearyl Alcohol, Dimethicone, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Macrogol Cetostearyl Ether 20, Methylcellulose, Purified Water, Sodium Methylparaben, Sodium Propylparaben.

Questions?

Contact: 1.848.373.2075

Product label

INGREDIENTS AND APPEARANCE

FIRST AID BURN 
lidocaine hydrochloride,benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82749-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82749-009-01	144 in 1 BOX	06/01/2024
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	06/01/2024

Labeler - Epic Medical Supply Corp (101423894)