Sore Throat
FDA Label NDC 70005-035

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Sore Throat (NDC 70005-035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor or dentist if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Phenol 1.4%

Purpose

Oral anesthetic/analgesic

Uses

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

Warnings

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

  • 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

  • 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,

ask doctor before use.

Keep Out Of Reach Of Children.

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

Directions

  • 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

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

Inactive Ingredients

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

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

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