FIRST AID ONLY FIRST AID/BURN- lidocaine hydrochloride and benzalkonium chloride cream 
Acme United Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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First Aid Only First Aid/Burn Cream

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 1.800.835.2263

carton label Carton Label

FIRST AID ONLY FIRST AID/BURN 
lidocaine hydrochloride and benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5011(NDC:50382-022)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5011-000.9 g in 1 PACKET; Type 0: Not a Combination Product08/30/2021
2NDC:0924-5011-0212 in 1 CARTON08/30/2021
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0924-5011-0325 in 1 CARTON08/30/2021
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:0924-5011-0110 in 1 CARTON08/30/2021
40.9 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:0924-5011-04144 in 1 CARTON08/30/2021
50.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/30/2021
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-5011) , repack(0924-5011)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-5011) , repack(0924-5011)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation117825595relabel(0924-5011) , repack(0924-5011)

Revised: 8/2021
Document Id: caa678ff-41a5-eaca-e053-2a95a90a159b
Set id: caa67a05-bdbd-c380-e053-2995a90a0bf1
Version: 1
Effective Time: 20210830
 
Acme United Corporation