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

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

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

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

When using this product

avoid contact with eyes

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 the reach of children.

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

Other information

Store at room temperature

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

Inactive ingredients

aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, triethanolamine

Questions?

1-800-835-2263

Carton ImageCarton Image

FIRST AID ONLY FIRST AID/ BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5711(NDC:59898-902)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5711-0410 in 1 CARTON04/08/2019
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-5711-026 in 1 CARTON04/08/2019
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0924-5711-036 in 1 BAG04/08/2019
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:0924-5711-010.9 g in 1 PACKET; Type 0: Not a Combination Product04/08/2019
5NDC:0924-5711-0510 in 1 CARTON04/08/2019
50.9 g in 1 PACKET; Type 0: Not a Combination Product
6NDC:0924-5711-0612 in 1 CARTON04/08/2019
60.9 g in 1 PACKET; Type 0: Not a Combination Product
7NDC:0924-5711-0720 in 1 CARTON04/08/2019
70.9 g in 1 PACKET; Type 0: Not a Combination Product
8NDC:0924-5711-0820 in 1 CARTON04/08/2019
80.9 g in 1 PACKET; Type 0: Not a Combination Product
9NDC:0924-5711-0925 in 1 CARTON04/08/2019
90.9 g in 1 PACKET; Type 0: Not a Combination Product
10NDC:0924-5711-1025 in 1 CARTON04/08/2019
100.9 g in 1 PACKET; Type 0: Not a Combination Product
11NDC:0924-5711-1150 in 1 CARTON04/08/2019
110.9 g in 1 PACKET; Type 0: Not a Combination Product
12NDC:0924-5711-1260 in 1 CARTON04/08/2019
120.9 g in 1 PACKET; Type 0: Not a Combination Product
13NDC:0924-5711-13144 in 1 CARTON04/08/2019
130.9 g in 1 PACKET; Type 0: Not a Combination Product
14NDC:0924-5711-14144 in 1 CARTON04/08/2019
140.9 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 finalpart34804/08/2019
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-5711) , repack(0924-5711)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-5711) , repack(0924-5711)

Revised: 12/2020
Document Id: b714031d-fa88-aa7e-e053-2995a90a96c4
Set id: 860d767d-63b9-127a-e053-2a91aa0a3f12
Version: 2
Effective Time: 20201222
 
Acme United Corporation