S.t.37 Solution
FDA Label NDC 69846-860

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Numark Brands, Inc for the product S.t.37 (NDC 69846-860). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, warnings and precautions, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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