FIRST AID ONLY FIRST AID/BURN- lidocaine hydrochloride and 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]

SPL UNCLASSIFIED SECTION

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 ▪a rash or allergic reaction occurs

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 in a cool dry area 150 – 250C (590 – 770F)

INACTIVE INGREDIENTS

butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium

QUESTIONS

Questions 1.800.835.2263

PRINCIPAL DISPLAY PANEL

carton label

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5011(NDC:50382-022)
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)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)
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: 0924-5011-00	0.9 g in 1 PACKET; Type 0: Not a Combination Product	08/30/2021
2	NDC: 0924-5011-02	12 in 1 CARTON	08/30/2021
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0924-5011-03	25 in 1 CARTON	08/30/2021
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0924-5011-01	10 in 1 CARTON	08/30/2021
4		0.9 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0924-5011-04	144 in 1 CARTON	08/30/2021
5		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	08/30/2021

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-5011) , repack(0924-5011)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-5011) , repack(0924-5011)