Label: OUTGRO- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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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
    BENZOCAINE
    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 DrugM01701/01/2013
    Labeler - Medtech Products Inc. (122715688)
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