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  5. Label Information: S.t.37

FDA Label for S.t.37

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. WARNINGS AND PRECAUTIONS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. STOP USE AND ASK A DOCTOR OR DENTIST IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. OTC - QUESTIONS
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

S.t.37 Product Label

The following document was submitted to the FDA by the labeler of this product Numark Brands, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



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

Otc - Pregnancy Or Breast Feeding



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


Otc - 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

    • 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.


Otc - Questions



Questions  call 1-800-331-0221


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 LABORATORIES INC.
Edison, NJ 08818

B10082
Rev. 1/02

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 LABORATORIES INC.
Edison, NJ 08818



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