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| Product NDC Code | 67172-113 | ||||
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| Drug Name | Chloraseptic sore throat menthol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 616480, 1101850 |
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| Application Number | part356 | ||||
| Labeler Name | Prestige Brands Holdings, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Phenol 1.4%
Active ingredient Phenol 1.4%
Active ingredient Phenol 1.4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
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.
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, FD&C Red #40, FD&C Yellow #6, flavor, glycerin, purified water, sodium saccharin, sodium citrate
Inactive ingredients FD&C red no. 40, flavors, glycerin, purified water, sodium chloride, sodium citrate, sodium saccharin, sucralose
Inactive ingredients D&C green no. 5, D&C yellow no. 10, FD&C green no. 3, flavor, glycerin, purified water, sodium saccharin, sucralose
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
Uses For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
Uses For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic/Analgesic
Purpose Oral Anesthetic/Analgesic
Purpose Oral Anesthetic/Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Chloraseptic Sore Throat Citrus Phenol PHENOL PHENOL CITRIC ACID MONOHYDRATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN WATER SACCHARIN SODIUM SODIUM CITRATE Chloraseptic Sore Throat Cherry Phenol PHENOL PHENOL FD&C RED NO. 40 GLYCERIN WATER SODIUM CHLORIDE SODIUM CITRATE SACCHARIN SODIUM SUCRALOSE Chloraseptic Sore Throat Menthol Phenol PHENOL PHENOL D&C GREEN NO. 5 D&C YELLOW NO. 10 FD&C GREEN NO. 3 GLYCERIN WATER SACCHARIN SODIUM SUCRALOSE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Chloraseptic ® Phenol/Oral Anesthetic CITRUS 6 FL OZ (177 mL) Chloraseptic® Phenol/Oral Anesthetic CITRUS 6 FL OZ (177 mL)
PRINCIPAL DISPLAY PANEL Chloraseptic ® Phenol/Oral Anesthetic CHERRY Flavor 6 FL OZ (177 mL) Chloraseptic® Phenol/Oral Anesthetic CHERRY Flavor 6 FL OZ (177 mL)
PRINCIPAL DISPLAY PANEL Chloraseptic ® Phenol/Oral Anesthetic MENTHOL Flavor| 6 FL OZ (177 mL) Chloraseptic® Phenol/Oral Anesthetic MENTHOL Flavor| 6 FL OZ (177 mL)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature check expiration date before using.
Other information store at room temperature check expiration date before using.
Other information store at room temperature check expiration date before using
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-552-7932 Chloraseptic.com Drug Facts
Questions? 1-800-552-7932 Chloraseptic.com Drug Facts
Questions? 1-800-552-7932 Chloraseptic.com
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not exceed recommended dosage.
When using this product do not exceed recommended dosage.
When using this product do not exceed recommended dosage.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
If pregnant or breast-feeding, ask a health care professional before use.
If pregnant or breast-feeding, ask a health care professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 dosage. 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 a health care professional 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.
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 dosage. 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 a health care professional 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.
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 dosage. 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 a health care professional 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API