FIRST AID ONLY FIRST AID/BURN- lidocaine hydrochloride, benzalkonium chloride cream

First Aid Only First Aid/Burn by

Drug Labeling and Warnings

First Aid Only First Aid/Burn by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 0.5%

Purpose

First Aid Antiseptic

External Analgesic

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor: cuts, scrapes, burns.

Warnings

For external use only.

Do not use

▪in the eyes ▪over large areas of the body ▪in large quantities, particularly over raw surfaces or blistered areas ▪if you are allergic to any of the ingredients ▪on deep puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

▪condition worsens or clears up and occurs again within a few days ▪symptoms persist for more than 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily.

Children under 2- Consult a doctor



Other Information

Store at room temperature

Inactive Ingredients

butylated hydroxytoluene, cetostearyl alcohol, dimethicone, edetate sodium, glycerin, glyceryl monostearate, isopropyl myristate, macrogol cetostearyl ether 20, methylcellulose, purified water, sodium methylparaben, sodium propylparaben

Questions

1.800.835.2263

PRINCIPAL DISPLAY PANEL

Carton Label

INGREDIENTS AND APPEARANCE

FIRST AID ONLY FIRST AID/BURN 
lidocaine hydrochloride, benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5730(NDC:61040-007)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	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)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5730-00	0.9 g in 1 PACKET; Type 0: Not a Combination Product	10/16/2023
2	NDC: 0924-5730-02	12 in 1 CARTON	10/16/2023
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0924-5730-03	25 in 1 CARTON	10/16/2023
3		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	M003	10/16/2023

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-5730) , repack(0924-5730)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	repack(0924-5730) , relabel(0924-5730)