Aseptil Rojo

Drug Facts

Composition & Product

Active Ingredients

Phenol (1.4 mg)

Inactive Ingredients

Citric Acid Acetate Fd&c Red No. 40 Glycerin Saccharin Sodium Propylene Glycol Sodium Citrate Water

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-02-21

Medication Information

Warnings and Precautions

Warnings

Sore throat warning: Sever 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 use more thani directed

Stop use and ask a doctor if

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

Indications and Usage

Uses

for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Dosage and Administration

Directions

Apply to the affected area (five sprays)
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 ageshould be supervised in the use of the product.
Children under 3 years of age:Consult a dentist or doctor.

Description

Active Ingredient Phenol 1.4%

Section 50565-1

Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, saccharin sodium, water.

Section 51945-4

Section 53413-1

Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

Section 53414-9

If pregnant or breast feeding, ask a health professional befre use.

Section 55105-1

Purpose

Oral Analgesic/Anesthetic

Section 55106-9

Active Ingredient

Phenol 1.4%

Structured Label Content

Indications and Usage (34067-9)

Uses

for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Dosage and Administration (34068-7)

Directions

Apply to the affected area (five sprays)
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 ageshould be supervised in the use of the product.
Children under 3 years of age:Consult a dentist or doctor.

Warnings and Precautions (34071-1)

Warnings

Sore throat warning: Sever 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 use more thani directed

Stop use and ask a doctor if

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

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, saccharin sodium, water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional befre use.

Section 55105-1 (55105-1)

Purpose

Oral Analgesic/Anesthetic

Section 55106-9 (55106-9)

Active Ingredient

Phenol 1.4%

Advanced Ingredient Data

[{"name": "CITRIC ACID ACETATE", "unii": "DSO12WL7AU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOL", "unii": "339NCG44TV", "classCode": "ACTIB", "strengthNumerator": "1.4", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.", "34068-7": "Directions Apply to the affected area (five sprays) 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 the product. Children under 3 years of age: Consult a dentist or doctor.", "34071-1": "Warnings Sore throat warning: Sever 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 use more thani directed Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops difficulty in breathing occurse", "50565-1": "Keep this and all drugs out of reach of children . In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away. ", "51727-6": "Inactive ingredients citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, saccharin sodium, water.", "53413-1": "Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern", "53414-9": "If pregnant or breast feeding, ask a health professional befre use.", "55105-1": "Purpose Oral Analgesic/Anesthetic", "55106-9": "Active Ingredient Phenol 1.4%"}