Label: FIRST AID AND BURN cream

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated April 2, 2010

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  • SPL UNCLASSIFIED SECTION

    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 & Burn Cream – Carton Label
  • INGREDIENTS AND APPEARANCE
    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)
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