S.t.37
Hexylresorcinol
Numark Brands, Inc
Human Otc Drug
NDC 69846-860S.t.37 also known as Hexylresorcinol is a human otc drug labeled by 'Numark Brands, Inc'. National Drug Code (NDC) number for S.t.37 is 69846-860. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in S.t.37 drug includes Hexylresorcinol - 1.1 mg/mL . The currest status of S.t.37 drug is Active.
Drug Information:
| Drug NDC: | 69846-860 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | S.t.37 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hexylresorcinol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Numark Brands, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HEXYLRESORCINOL - 1.1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 20 Nov, 1929 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | NUMARK BRANDS, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | R9QTB5E82N
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69846-860-00 | 1 BOTTLE in 1 AMPULE (69846-860-00) / 236.5 mL in 1 BOTTLE | 20 Nov, 1929 | N/A | No |
| 69846-860-01 | 1 BOTTLE in 1 CARTON (69846-860-01) / 473 mL in 1 BOTTLE | 20 Nov, 1929 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredient purposes hexylresorinol 0.1% oral pain reliever first aid antiseptic
Product Elements:
S.t.37 hexylresorcinol hexylresorcinol hexylresorcinol citric acid monohydrate edetate disodium glycerin propylene glycol sodium bisulfite sodium citrate water carton label
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
Warnings:
Warnings for external use only
Warnings and Cautions:
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:
Warnings for external use only
When Using:
When using this product do not exceed recommended dosage
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
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
Stop Use:
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
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 â won't stain s.t.37 kills common pathogenic bacteria quickly â 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
Further Questions:
Questions call 1-800-214-2379