S.T.37 (HEXYLRESORCINOL) SOLUTION [NUMARK BRANDS, INC]

S.T.37 (HEXYLRESORCINOL) SOLUTION [NUMARK BRANDS, INC]
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NDC 69846-860-00, 69846-860-01
Set ID 7d7acca2-aa8a-5272-e813-faab039cc798
Category HUMAN OTC DRUG LABEL
Packager NUMARK BRANDS, INC
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredient Purposes
    Hexylresorinol 0.1% Oral Pain Reliever
      First aid antiseptic
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  • INDICATIONS & USAGE

    Uses  temporarily relieves:

    • minor irritations of the mouth
    • minor pain in the mouth
    • sore mouth
    • sore throat
    • first aid to help prevent skin infection in minor cuts, scrapes, and burns
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  • Warnings

    For external use only

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  • WARNINGS AND PRECAUTIONS

    Sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

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  • Do not use

    • In the eyes
    • over large areas of the body
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  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • When using this product

    • do not exceed recommended dosage
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  • Stop use and ask a doctor if

    • condition persists
    • condition worsens
    • you need to use product longer than 1 week
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  • Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, and redness persist or worsen
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

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  • 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 right away.

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  • DOSAGE & ADMINISTRATION

    Directions  (as a First Aid antiseptic)

    • use full strength
    • clean affected area
    • apply a small amount of product on the area
    • use 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged let dry first
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  • DOSAGE & ADMINISTRATION

    Directions  (as an Oral pain reliever)

    • apply to affected area
    • gargle, swish around, or allow to remain in place for at least one minute and then spit out
    adults and children
    2 years old and over
    use up to 4 times
    daily or as directed
    by a dentist or doctor
    children under 2
    years old
    ask a dentist or
    doctor
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  • Other Information

    • store at controlled room temperature 59° - 86°F (15° - 30°C)
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  • Inactive Ingredients

    citric acid, edetate disodium, glycerin, propylene glycol, sodium bisulfite, sodium citrate, purified water.

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  • QUESTIONS

    Questions  call 1-800-214-2379

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    8 oz SIZE
    2.5 more ounces at the same low price


    S.T.37®
    FIRST AID ANTISEPTIC/ORAL PAIN RELIEVER
    SOLUTION

    FOR BURNS, CUTS, ABRASIONS & HYGIENIC CARE OF THE MOUTH.

    Do not use if foil seal under cap is broken or missing at time of purchase

    8 FL OZ (236.5 mL)

    WON'T STING — WON'T STAIN

    S.T.37 kills common pathogenic bacteria quickly — on contact!

    Laboratory tests have established S.T.37 antiseptic solution as a general antiseptic for household use.

    S.T.37 is pleasant to use because it produces little or no stinging or burning. In fact, it soothes irritated areas.

    S.T.37 does not stain the skin or leave an order.

    Everyday Uses for S.T.37 
    Cuts & Abrasions: Apply full strength S.T.37 into the cut or over the injured area. Since it is germicidal for the common pathogenic bacteria, S.T.37 may minimize the development of infection. Excellent for cleansing cuts and scrapes.

    Burns: Apply full strength S.T.37 for treatment of minor burns. S.T.37 combats the cause of infections.

    Hygienic Care of Mouth: Use undiluted and gargle or rinse to help keep mouth clean and fresh. S.T.37 temporarily relieves minor pain and protects irritated areas of a sore mouth or throat.
     
    Distributed by Numark Brands, Inc.
    27070 Miles Rd, Suite A, Solon Ohio 44139
    www.numarkbrands.com

    B10082
    Rev. 3/18

    Carton

    S.T.37®
    FIRST AID ANTISEPTIC/ORAL PAIN RELIEVER
    SOLUTION

    FOR BURNS, CUTS, ABRASIONS & HYGIENIC CARE OF THE MOUTH

    8 FL OZ (236.5 mL)

    Do not use if foil seal under cap is broken or missing at time of purchase

    S.T.37 kills common pathogenic bacteria quickly - on contact!

    Laboratory tests have established S.T.37 antiseptic solution as a general antiseptic for household use.

    S.T.37 is pleasant to use because it produces little or no stinging or burning. In fact, it soothes irritated areas.

    S.T.37 does not stain the skin or leave an order.

    Everyday Uses for S.T.37 
    Cuts & Abrasions: Apply full strength S.T.37 into the cut or over the injured area. Since it is germicidal for the common pathogenic bacteria, S.T.37 may minimize the development of infection. Excellent for cleansing cuts and scrapes.

    Burns: Apply full strength S.T.37 for treatment of minor burns. S.T.37 combats the cause of infections.

    Hygienic Care of Mouth: Use undiluted and gargle or rinse to help keep mouth clean and fresh. S.T.37 temporarily relieves minor pain and protects irritated areas of a sore mouth or throat.
     
    Distributed by Numark Brands, Inc.
    27070 Miles Rd, Suite A, Solon Ohio 44139 1-800-214-2379
    www.numarkbrands.com Rev. 3/18 J12008

    Label
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  • INGREDIENTS AND APPEARANCE
    S.T.37  
    hexylresorcinol solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69846-860
    Route of Administration ORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hexylresorcinol (UNII: R9QTB5E82N) (Hexylresorcinol - UNII:R9QTB5E82N) Hexylresorcinol 1.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Bisulfite (UNII: TZX5469Z6I)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69846-860-00 1 in 1 AMPULE 11/20/1929
    1 236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:69846-860-01 1 in 1 CARTON 11/20/1929
    2 473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/20/1929
    Labeler - NUMARK BRANDS, INC (080184668)
    Establishment
    Name Address ID/FEI Business Operations
    RARITAN PHARMACEUTICALS INC 127602287 manufacture(69846-860)
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