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First aid and Burn by B8 Sales, Inc.

Medically reviewed on April 2, 2018

Dosage form: cream
Ingredients: Benzalkonium Chloride 1.3mg in 1g, Lidocaine Hydrochloride 5mg in 1g
Labeler: B8 Sales, Inc.
NDC Code: 50607-5700

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.

PIO Put it on®

First Aid & Burn CreamTM

  • For Temporary Relief of Pain Associated with Minor Burns
  • Helps Protect Against Harmful Bacteria

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
  • for the temporary relief of pain associated with minor bums
  • helps protect against harmful bacteria

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
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

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

  • For Temporary Relief of Pain Associated with Minor Burns
  • Helps Protect Against Harmful Bacteria

25 Packets

Each Packet Net.Wt.0.9gm

FIRST AID AND BURN 
first aid and burn cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50607-5700
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride1.3 mg  in 1 g
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe 
alcohol 
methylparaben 
mineral oil 
paraffin 
propylparaben 
water 
petrolatum 
white wax 
Product Characteristics
Colorwhite (white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50607-5700-125 POUCH (25 POUCH) in 1 BOX
1.9 g in 1 POUCH
2NDC:50607-5700-2144 POUCH (144 POUCH) 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)

 
B8 Sales, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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