GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE - benzalkonium chloride, lidocaine cream 
Genuine First Aid

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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Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe

Active Ingredients

ACTIVE INGREDIENTS:

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%


Purpose

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 eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week

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 puncture wounds, animal bites or serious burns.

When using this product, avoid contact with the 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 reach of Children.

If ingested, contact a Poison Control Center right away.

Directions



Adults and children 2 years of age and older

clean 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).

Taper evident sealed packets.

Do not use packet if opened or torn.

Inactive Ingredients

Peregal-O

Glycerin monostearate

Glycerol

Purified Water.

LOT/EXP:                                    Made in CHINA

20130301



GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.

BurnCream

GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
benzalkonium chloride, lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52124-0004-10.9 g in 1 PACKET
2NDC:52124-0004-26 in 1 BOX
20.9 g in 1 PACKET
3NDC:52124-0004-3100 in 1 CARTON
30.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333A04/23/2010
Labeler - Genuine First Aid (619609857)

Revised: 4/2012
Document Id: fbc705dd-eaf8-41cf-9f8b-59032951c9a7
Set id: 2e37d8c7-4137-48c9-a621-ff711b9c3b2b
Version: 16
Effective Time: 20120425
 
Genuine First Aid