Chloraseptic Warming Sore Throat Spray

Manufacturer
Denison Pharmaceuticals, Inc.
Effective date
2017-05-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:00:15

Label at a glance#

ProductChloraseptic Warming Sore Throat
Active ingredientPHENOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults and children 6 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 6 years of age : consult a doctor or dentist.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 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 a 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 dosage.

Stop use and ask a doctor or dentist if

OTC - ASK DOCTOR 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 a 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 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 6 years of age: consult a doctor or dentist.

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature.
  • Check expiration date before using.
  • Contains FD&C yellow 5 (tartrazine) as a color additive

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel color, citric acid, FD&C yellow no. 5, FD&C yellow no.6, glycerin, flavors, purified water, saccharin sodium, sodium citrate, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic Warming Sore Throat Spray
Phenol/Oral Anesthetic

Honey Lemon
Flavor | 6 FL OZ (177 mL)

Chloraseptic Warming Sore Throat Spray Phenol/Oral Anesthetic Honey Lemon Flavor | 6 FL OZ (177 mL)Chloraseptic Warming Sore Throat Spray Phenol/Oral Anesthetic Honey Lemon Flavor | 6 FL OZ (177 mL)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-10260295-1026-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
f49b6e1e-e825-4936-95cc-15df268dc2a9782759c2-4755-411f-bb4d-aa9a1b3db4422017-05-03WarningsExact identifier
spl id: f49b6e1e-e825-4936-95cc-15df268dc2a9
spl set id: 782759c2-4755-411f-bb4d-aa9a1b3db442

Reported adverse events (FAERS/openFDA)#

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