Label: PROTECTION- isopropyl alcohol, benzocaine, alcohol, aspirin kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 February 1, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredient:

    Isopropyl Alcohol, 70% v/v

  • Alcohol Cleansing Pad Use

    Use: For preparation of the skin befoire injection.

  • WARNINGS

    Warnings: For external use only.

  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame

  • DO NOT USE

    Do not use: with electrocautery, in the eyes.

  • STOP USE

    Stop use if irritation and redness develop.

    If condition persists for more than 72 hours,

    consult your doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed,

    get medical help or contact a Poison Control

    Center right away.

  • WHEN USING

    Directions:    Wipe injection site vigorously and

  • STORAGE AND HANDLING

    Other information:    Store at room temperature

    15 - 30 degree Celsius (59 - 86 Farenheit)

  • INACTIVE INGREDIENT

    Inactive Ingredient:    Purified water

  • DESCRIPTION

    LOT/EXP:                Made in CHINA

    20140301

  • Active Ingredient

    Benzocaine, 6% w/v.
    SD alcohol, 60% w/v

  • 52124-0008

    Use: for the temporary relief of pain and itching associated with minor burn, scrapes, and insect bites.

  • WARNINGS

    Warnings: For external use only.

    Avoid contact with eyes.  If this happens,

    rinse thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help

    or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame.

  • DO NOT USE

    Do not use: In eyes, on broken skin, deep

    puncture wounds.  If unusual redness, swelling,

    irritation or other symptoms occur, consult a

    physician immediately.

  • DESCRIPTION

    Made in CHINA

    LOT/EXP:

  • 52124-0008 Inactive Ingredients

    Inactive Ingredient: Purified Water

  • Active Ingredient (in each tablet)

    Aspirin 81 mg (NSAID *)


  • INDICATIONS & USAGE

    Uses

    Temporary relief of minor aches, pains and headaches

    to reduce fever associated with colds, sore throats, teething

  • WARNINGS

    Warnings

    Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome.

    Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems

    takes a blood thinning (anticoagulant) or steroid drug

    takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

    takes more or for a longer time than directed

    is age 60 or older


    has 3 or more alcoholic drinks every while using this product.

  • DO NOT USE

    Do not use

    if you are allergic to aspirin or any other pain relievers/fever reducers

    for more than 10 days for pain unless directed by a doctor

    for more than 3 days for fever unless directed by a doctor

    for at least 7 days after a tonsillectomy or oral surgery

  • ASK DOCTOR

    Ask a doctor before use if you have;

    asthma

    stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems

    a child experiencing arthritis pain

    if you are;

    allergic to aspirin

    taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis


  • STOP USE

    Stop use and ask a doctor if;

    an allergic reaction occurs, Seek medical help right away

    pain or fever persists

    new or unexpected symptoms occur

    redness or swelling is present

    ringing in ears or loss of hearing occurs

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.  It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions  Do not use more than directed

    Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours,  Do not exceed 48 tablets in 24 hours unless directed by a doctor.

    Children Under 12 years: Consult a doctor.

  • STORAGE AND HANDLING

    Store at room temperature

    tamper evident sealed packets

    do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients      flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose

  • DESCRIPTION

    MADE IN USA

    Distributed by GENUINE FIRST AID

    600 Cleveland Str Suite 400, Clearwater, FL 33755

  • Alcohol Cleansing Wipe Purpose

    Antiseptic

  • Insect Sting Relief Pad Purpose

    Antiseptic

  • Aspirin Purpose

    Analgesic/Antipyretic

  • PRINCIPAL DISPLAY PANEL

    Alcohol Cleansing Pad

  • PRINCIPAL DISPLAY PANEL

    Insect Sting Relief Pad

  • PRINCIPAL DISPLAY PANEL

    ChewableAspirin

  • PRINCIPAL DISPLAY PANEL

    Kit5 Protection

  • INGREDIENTS AND APPEARANCE
    PROTECTION 
    isopropyl alcohol, benzocaine, alcohol, aspirin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0114
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0114-11 in 1 KIT04/23/2010
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 3
    Part 1 of 3
    ALCOHOL CLEANSING PAD 
    isopropyl alcohol liquid
    Product Information
    Item Code (Source)NDC:52124-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2010
    Part 2 of 3
    INSECT STING RELIEF PAD 
    benzocaine,alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.6 mg  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/23/2010
    Part 3 of 3
    CHEWABLE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Item Code (Source)NDC:52124-0012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM CATION (UNII: LYR4M0NH37)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colororange (ORANGE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code ASPIRIN
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34304/23/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34804/23/2010
    Labeler - Genuine First Aid LLC (619609857)