OTC Medication Information: S.T.37

S.T.37 — hexylresorcinol solution
NUMARK BRANDS, INC

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.

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

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

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

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

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

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 children2 years old and over use up to 4 timesdaily or as directedby a dentist or doctor
children under 2years old ask a dentist ordoctor

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 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
(click image for full-size original)

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
(click image for full-size original)
S.T.37 hexylresorcinol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69846-860
Route of Administration ORAL, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hexylresorcinol (Hexylresorcinol) Hexylresorcinol 1.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate
Edetate Disodium
Glycerin
Propylene Glycol
Sodium Bisulfite
Sodium Citrate
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69846-860-00 1 BOTTLE in 1 AMPULE contains a BOTTLE
1 236.5 mL in 1 BOTTLE This package is contained within the AMPULE (69846-860-00)
2 NDC:69846-860-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 473 mL in 1 BOTTLE This package is contained within the CARTON (69846-860-01)
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 Operations
RARITAN PHARMACEUTICALS INC 127602287 manufacture (69846-860)

Revised: 05/2019 NUMARK BRANDS, INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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