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 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

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 or apply over large areas of the body
• longer than 1 week unless directed by a doctor
• in large quantities, particularly over raw surfaces or blistered areas
  

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

Keep out of the 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 on the area 1 to 3 times daily
•     may be covered with a sterile bandage
•     children under 2 years of age: consult a doctor
  

Other information

• store at room temperature (do not freeze)
  
• tamper evident sealed packets
• do not use if packet is opened or torn
• you may report a serious reaction to this product to 800-275-3433
  

Inactive ingredients

water, mineral oil, stearic acid, glyceryl stearate se, glycerin, Peg-100, cetyl alcohol, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, aloe barbadensis leaf juice, triethanolamine, disodium EDTA

Questions?

800-275-3433   info@waterjel.com   www.waterjel.com

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: 59898-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	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
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: 59898-902-01	1728 in 1 CARTON	04/20/2010
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 59898-902-02	144 in 1 BOX, UNIT-DOSE	04/20/2010
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 59898-902-03	25 in 1 BOX, UNIT-DOSE	04/20/2010
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 59898-902-36	0.9 g in 1 PACKET; Type 0: Not a Combination Product	04/20/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/20/2010

Labeler - Water-Jel Technologies (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(59898-902)