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, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCI 0.5%

Purpose

Topical Analgesic

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Topical Antiseptic

Use(s)

For the temporary relief of pain and itching associated with:

Sunburn Minor burns Insect bites 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.

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, Gylcerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

Questions?

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

Label

PS-2309 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: 58228-2309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	50 mg  in 10000 mg
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg  in 10000 mg

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

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-2309-1	2000 in 1 CARTON	07/31/2023
1		900 mg 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)