FIRST AID BURN  - lidocaine hydrochloride and benzalkonium chloride cream 
Water-Jel Technologies

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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Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl  0.5%


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

Inactive ingredients

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

Questions?

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

Principal Display Panel

Image of PDP

FIRST AID BURN  
first aid burn cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-902
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE ) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM ) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
LIGHT MINERAL OIL 
STEARIC ACID 
POLYETHYLENE GLYCOL 
CETYL ALCOHOL 
TROLAMINE 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
ALOE VERA LEAF 
WATER 
PROPYLPARABEN 
GLYCERYL MONOSTEARATE 
Packaging
#Item CodePackage Description
1NDC:59898-902-011728 in 1 CARTON
10.9 g in 1 PACKET
2NDC:59898-902-02144 in 1 BOX, UNIT-DOSE
20.9 g in 1 PACKET
3NDC:59898-902-0325 in 1 BOX, UNIT-DOSE
30.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/20/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture

Revised: 04/2010
Document Id: 6da3f11f-f15a-4c9b-b092-5468fd7b3e0f
Set id: 25ebf112-8ac3-4402-9a87-00e454ab7efa
Version: 3
Effective Time: 20100420
 
Water-Jel Technologies