Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 7d7acca2-aa8a-5272-e813-faab039cc798
Routes
ORAL TOPICAL
Published
Effective Date 2019-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hexylresorcinol (1.1 mg)
Inactive Ingredients
Citric Acid Monohydrate Edetate Disodium Glycerin Propylene Glycol Sodium Bisulfite Sodium Citrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1929-11-20

Description

Active Ingredient Purposes Hexylresorinol 0.1% Oral Pain Reliever   First aid antiseptic


Medication Information

Indications and 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
Dosage and 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
Description

Active Ingredient Purposes Hexylresorinol 0.1% Oral Pain Reliever   First aid antiseptic

Section 43685-7

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.

Section 50565-1

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

Section 53413-1

Questions  call 1-800-214-2379

Section 53414-9

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

Section 55105-1
Active Ingredient Purposes
Hexylresorinol 0.1% Oral Pain Reliever
  First aid antiseptic
Warnings

For external use only

Do Not Use
  • In the eyes
  • over large areas of the body
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.

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
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
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

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

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

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Section 43685-7 (43685-7)

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.

Section 50565-1 (50565-1)

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

Section 53413-1 (53413-1)

Questions  call 1-800-214-2379

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active Ingredient Purposes
Hexylresorinol 0.1% Oral Pain Reliever
  First aid antiseptic
Warnings

For external use only

Do Not Use (Do not use)
  • In the eyes
  • over large areas of the body
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.

When Using This Product (When using this product)
  • do not exceed recommended dosage
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition persists
  • condition worsens
  • you need to use product longer than 1 week
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label.principal Display Panel (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

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

Stop Use and Ask A Doctor Or Dentist If (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

Advanced Ingredient Data


Raw Label Data

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