Label: OUTGRO- benzocaine liquid

  • 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 October 2, 2017

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  • SPL UNCLASSIFIED SECTION

    Outgro®

    PAIN RELIEVING LIQUID

    Drug Facts

  • Active Ingredient

    Benzocaine 20% w/v

  • Purpose

    Topical analgesic

  • Use

    For the temporary relief of pain associated with minor skin irritations.

  • Warnings

    ■ For external use only.

    ■ Extremely Flammable. Keep away from fire or flame. Avoid smoking during use and until product has dried.

    When using this product:

    avoid contact with eyes.

    Stop use and ask a doctor if:

    ■ condition worsens ■ condition does not improve in 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 olderUsing applicator, apply to affected area not more than 3 to 4 times daily
    Children under 2 years of ageConsult a doctor
  • Other Information

    ■ store at room temperature away from heat.

  • Inactive Ingredients

    Alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, PEG-8

    Questions?

    1-800-443-4908

  • Principal Display Panel

    Outgro
    BENZOCANE
    PAIN RELIEVING
    LIQUID
    .31 FL OZ/ 9 mL

    Outgro BENZOCANE PAIN RELIEVING LIQUID .31 FL OZ/ 9 mL

  • INGREDIENTS AND APPEARANCE
    OUTGRO 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-531
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE18.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-531-111 in 1 BOX01/01/2013
    19 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/01/2013
    Labeler - Medtech Products Inc. (122715688)
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