FDA.reportPublic FDA data

Sore Throat

Manufacturer
We Care Distributor Inc. | PURINE PHARMA LLC
Effective date
2016-09-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:47:14

Label at a glance#

ProductSore Throat
Active ingredientPHENOL
Label structure8 sections

Indications and uses

For the temporary relief of occasional minor throat: irritation  pain sore mouth and sore throat

Dosage and administration

Adults and children 3 years of age and older: Apply to the affected area (one spray) Allow to remain in place for at least 15 seconds, then spit out Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product Children under 3 years of age: consult a doctor or dentist Before using the first time, remove the protective neck band and its dust...

Storage and handling

store at room temperature check expiration date before using retain carton for future reference

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%

Purpose

OTC - PURPOSE SECTION

Oral anesthetic/analgesic

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of occasional minor throat:
  • irritation 
  • pain
  • sore mouth and
  • sore throat

Warnings

WARNINGS SECTION

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dose
  • do not use for more than 2 days, Use only as directed
  • use of this container by more than one person may spread infection

Stop use and ask a doctor or dentist if

OTC - STOP USE SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask doctor before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 3 years of age and older:
  • Apply to the affected area (one spray)
  • Allow to remain in place for at least 15 seconds, then spit out
  • Use every 2 hours or as directed by a doctor or dentist.
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 3 years of age: consult a doctor or dentist
  • Before using the first time, remove the protective neck band and its dust cap from the tip. To spray, hold bottle straight up and press on the nozzle with index finger without tilting head. Fully depress pump all the way down with a firm even stroke. Wipe nozzle dry.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • check expiration date before using
  • retain carton for future reference

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, flavor, glycerin, purified water, saccharin sodium

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in Chloraseptic

FAST RELIEF

SORE THROAT SPRAY

PHENOL / ORAL ANESTHETIC

CHERRY FLAVOR

Instant-Acting

Relieves Sore Throat

See New Directions

Sore Throat Spray Label ImageSore Throat Spray Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198776phenol 1.4 % Mucosal SprayPSN3
198776phenol 14 MG/ML Mucosal SpraySCD3
198776phenol 1.4 % Mucosal SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-035-012020-01-31C16284748780-19d75b9cf-da7b-f424-e053-dadaa90a57ceSore Throat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-035-01Sore Throat30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-035SORE THROAT (PHENOL) SPRAY [WE CARE DISTRIBUTOR INC.]3Legacy NDC, 1 package rows20160924_15095229-f59d-4855-b38f-a090d661860a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-03570005-035-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOL339NCG44TVACTIB
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
35dbe896-ac5e-4810-9597-80f5e284d00115095229-f59d-4855-b38f-a090d661860a2016-09-23WarningsExact identifier
spl id: 35dbe896-ac5e-4810-9597-80f5e284d001
spl set id: 15095229-f59d-4855-b38f-a090d661860a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.