FIRST AID BURN CREAM cream

First Aid Burn Cream by

Drug Labeling and Warnings

First Aid Burn Cream by is a Otc medication manufactured, distributed, or labeled by ProStat First Aid LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Active Ingredient

Lidocaine Hydrochloride 0.5%

Purpose

Benzalkonium Chloride Topical Antiseptic

Lidocaine Hydrochloride Topical Analgesic

Use(s)

For the 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 dioctor 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.

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 in a cool, dry area 15º-25ºC (59º-77ºF)

Tamper evident sealed packets

Do not use any opened or torn packets

Inactive Ingredients

Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

Questions?

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

Label

First Aid Burn Cream

INGREDIENTS AND APPEARANCE

FIRST AID BURN CREAM 
first aid burn cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-2044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
CETETH-20 (UNII: I835H2IHHX)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-2044-2	1800 in 1 CASE	04/10/2023
1	NDC: 58228-2044-1	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	04/10/2023

Labeler - ProStat First Aid LLC (061263699)