FIRST AID AND BURN- first aid and burn cream 
B8 Sales, Inc.

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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PIO Put it on®

First Aid & Burn CreamTM

25 Packets

Each Packet Net.Wt.0.9gm

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

Warnings

For external use only.

Keep out of reach of children.

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

Do not use

  • in eyes ■ in large quantities ■ over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Stop use and ask a doctor if

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

Directions

Adults and children 2 years and over: clean affected area, apply small amount not more than 3 to 4 times daily Children under 2 years: do not use, consult a doctor

Other information

Inactive ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Principal Display Panel

First Aid & Burn Cream – Carton Label

PIO Put it on®

First Aid & Burn CreamTM

25 Packets

Each Packet Net.Wt.0.9gm

First Aid & Burn Cream – Carton Label
FIRST AID AND BURN 
first aid and burn cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50607-5700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 g
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe (UNII: V5VD430YW9)  
alcohol (UNII: 3K9958V90M)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
petrolatum (UNII: 4T6H12BN9U)  
white wax (UNII: 7G1J5DA97F)  
Product Characteristics
Colorwhite (white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50607-5700-125 in 1 BOX
1.9 g in 1 POUCH
2NDC:50607-5700-2144 in 1 BOX
2.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33305/01/2010
Labeler - B8 Sales, Inc. (833208635)

Revised: 4/2010
Document Id: ecdf4659-d30b-42a6-a987-168a2e391542
Set id: f58deae7-bc28-4832-aef7-7eece24aeae4
Version: 1
Effective Time: 20100402
 
B8 Sales, Inc.