Label: S.T.37- hexylresorcinol solution

  • NDC Code(s): 69846-860-00, 69846-860-01
  • Packager: NUMARK BRANDS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 19, 2023

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

  • ACTIVE INGREDIENT

    Active IngredientPurposes
    Hexylresorinol 0.1%Oral Pain Reliever
     First aid antiseptic
  • 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
  • Warnings

    For external use only

  • 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.

  • Do not use

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

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

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

    • condition persists
    • condition worsens
    • you need to use product longer than 1 week
  • 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
  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • 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
  • 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
  • Other Information

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

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

  • QUESTIONS

    Questions  call 1-800-214-2379

  • 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
  • INGREDIENTS AND APPEARANCE
    S.T.37  
    hexylresorcinol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69846-860
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hexylresorcinol (UNII: R9QTB5E82N) (Hexylresorcinol - UNII:R9QTB5E82N) Hexylresorcinol1.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69846-860-001 in 1 AMPULE11/20/1929
    1236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69846-860-011 in 1 CARTON11/20/1929
    2473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/20/1929
    Labeler - NUMARK BRANDS, INC (080184668)