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

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

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

PRINCIPAL DISPLAY PANEL

Carton Image

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5711(NDC:59898-902)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5711-04	10 in 1 CARTON	04/08/2019
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-5711-02	6 in 1 CARTON	04/08/2019
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0924-5711-03	6 in 1 BAG	04/08/2019
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0924-5711-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	04/08/2019
5	NDC: 0924-5711-05	10 in 1 CARTON	04/08/2019
5		0.9 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 0924-5711-06	12 in 1 CARTON	04/08/2019
6		0.9 g in 1 PACKET; Type 0: Not a Combination Product
7	NDC: 0924-5711-07	20 in 1 CARTON	04/08/2019
7		0.9 g in 1 PACKET; Type 0: Not a Combination Product
8	NDC: 0924-5711-08	20 in 1 CARTON	04/08/2019
8		0.9 g in 1 PACKET; Type 0: Not a Combination Product
9	NDC: 0924-5711-09	25 in 1 CARTON	04/08/2019
9		0.9 g in 1 PACKET; Type 0: Not a Combination Product
10	NDC: 0924-5711-10	25 in 1 CARTON	04/08/2019
10		0.9 g in 1 PACKET; Type 0: Not a Combination Product
11	NDC: 0924-5711-11	50 in 1 CARTON	04/08/2019
11		0.9 g in 1 PACKET; Type 0: Not a Combination Product
12	NDC: 0924-5711-12	60 in 1 CARTON	04/08/2019
12		0.9 g in 1 PACKET; Type 0: Not a Combination Product
13	NDC: 0924-5711-13	144 in 1 CARTON	04/08/2019
13		0.9 g in 1 PACKET; Type 0: Not a Combination Product
14	NDC: 0924-5711-14	144 in 1 CARTON	04/08/2019
14		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 not final	part348	04/08/2019

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-5711) , repack(0924-5711)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-5711) , repack(0924-5711)