Cool Relief Icy Menthol Oral Anesthetic

Cool Relief Icy Menthol Oral Anesthetic
SPL v3
SPL
SPL Set ID 3698a69f-b5c0-4235-8ef8-71c867f1ac0d
Route
ORAL
Published
Effective Date 2020-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (13.2 mg)
Inactive Ingredients
Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: R Shape: oval Color: green Size: 24 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-01

Description

Purpose Oral anesthetic


Medication Information

Description

Purpose Oral anesthetic

Uses

temporarily relieves occasional minor irritation and pain associated with

  • sore mouth
  • sore throat
Section 51945-4

Warnings

Do not use

  • in children under 5 years of age unless directed by a doctor

Sore throat warnings:

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.
Directions
  • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
  • do not bite or chew
Drug Facts

Purpose

Oral anesthetic

Other Information

protect from heat and moisture

Inactive Ingredients

extract of lemon balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), colors (carrot, spirulina), flavors (lemon-thyme, peppermint), starch syrup, sugar

Keep Out of Reach of Children.



Active Ingredient (in Each Drop)

Menthol, 13.2 mg


Structured Label Content

Uses

temporarily relieves occasional minor irritation and pain associated with

  • sore mouth
  • sore throat
Section 51945-4 (51945-4)

Warnings

Do not use

  • in children under 5 years of age unless directed by a doctor

Sore throat warnings:

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.
Directions
  • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
  • do not bite or chew
Drug Facts

Purpose

Oral anesthetic

Other Information

protect from heat and moisture

Inactive Ingredients

extract of lemon balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), colors (carrot, spirulina), flavors (lemon-thyme, peppermint), starch syrup, sugar

Keep Out of Reach of Children. (Keep out of reach of children.)



Active Ingredient (in Each Drop) (Active Ingredient (in each drop))

Menthol, 13.2 mg


Advanced Ingredient Data


Raw Label Data

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