FIRST AID BURN- benzalkonium chloride, lidocaine hydrochloride cream

First Aid Burn by

Drug Labeling and Warnings

First Aid Burn by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, Water-Jel Technologies. 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

• prevent skin infection
• for temporary relief of pain associated with minor burns

Warnings

For external use only

Do not use

• in or near the eyes
• if you are allergic to any of the ingredients
• lin large areas of the body, particularly over raw surfaces or blistered areas
• for more than 10 days

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

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

Keep out of reach of children

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

Directions

• adults and children 2 years of age and older:
• clean the affected area
• apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: consult a doctor

Other information

• tamper evident sealed packets
• do not use if packet is opened or torn
  

Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

Questions

1-800-430-5490

Principal Display Panel

INGREDIENTS AND APPEARANCE

FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0903
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0903-34	10 in 1 BOX, UNIT-DOSE	12/20/2017
1		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	part333A	12/20/2017

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	pack(0498-0903)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0903)