SPL v7
SPL
SPL Set ID f643f019-4fdf-4bca-a5f1-7e8b4e171572
Route
ORAL
Published
Effective Date 2014-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (.25 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-05

Description

Drug Facts Active Ingredient Phenol 0.6%...............Oral Pain Reliever Uses temporary relief of occasional minor irritation, pain, sore mouth, and sore throat. Warnings If used for sore throat: Consult a doctor promplty if sore throat is severe or persists more than 2 days accompanied by : rash swelling fever headache nausea vomiting Unless directed by a doctor do not administer to children under 3 years of age. If used for sore mouth: See your dentist or doctor promptly if sore mouth symptoms do not improve in 7 days. irritation, pain, or redness persists or worsens Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity. Keep out of reech of children. If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away. Directions Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor. Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product. Children under 6 years of age: consult a dentist or doctor Other information store at 15 o -30 o C (59 o -86 o F) Inactive ingredients boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Purpose

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


Medication Information

Purpose

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

Description

Drug Facts Active Ingredient Phenol 0.6%...............Oral Pain Reliever Uses temporary relief of occasional minor irritation, pain, sore mouth, and sore throat. Warnings If used for sore throat: Consult a doctor promplty if sore throat is severe or persists more than 2 days accompanied by : rash swelling fever headache nausea vomiting Unless directed by a doctor do not administer to children under 3 years of age. If used for sore mouth: See your dentist or doctor promptly if sore mouth symptoms do not improve in 7 days. irritation, pain, or redness persists or worsens Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity. Keep out of reech of children. If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away. Directions Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor. Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product. Children under 6 years of age: consult a dentist or doctor Other information store at 15 o -30 o C (59 o -86 o F) Inactive ingredients boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Label

Warnings Section

Warnings

If used for sore throat:

Consult a doctor promplty if sore throat is

  • severe or persists more than 2 daysaccompanied by :
  • rash
  • swelling
  • fever
  • headache
  • nausea
  • vomiting

Unless directed by a doctor do not administer to children under 3 years of age.

If used for sore mouth:

See your dentist or doctor promptly if

  • sore mouth symptoms do not improve in 7 days.
  • irritation, pain, or redness persists or worsens

Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

Otc Purpose Section

Uses

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

Inactive Ingredient Section

Inactive ingredients

boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Indications & Usage Section

Other information

  • store at 15o-30oC (59o-86oF)

Dosage & Administration Section

Directions

  • Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
  • Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.Children under 6 years of age: consult a dentist or doctor
  • Children under 6 years of age: consult a dentist or doctor

Otc Active Ingredient Section

Drug Facts

Active Ingredient

Phenol 0.6%...............Oral Pain Reliever

Uses

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

Warnings

If used for sore throat:

Consult a doctor promplty if sore throat is

  • severe or persists more than 2 days
  • accompanied by :
  • rash
  • swelling
  • fever
  • headache
  • nausea
  • vomiting

Unless directed by a doctor do not administer to children under 3 years of age.

If used for sore mouth:

See your dentist or doctor promptly if

  • sore mouth symptoms do not improve in 7 days.
  • irritation, pain, or redness persists or worsens

Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

Keep out of reech of children.

If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
  • Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.
  • Children under 6 years of age: consult a dentist or doctor

Other information

  • store at 15o-30oC (59o-86oF)

Inactive ingredients

boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Otc Keep Out of Reach of Children Section

Keep out of reech of children.

If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Label

Warnings Section (WARNINGS SECTION)

Warnings

If used for sore throat:

Consult a doctor promplty if sore throat is

  • severe or persists more than 2 daysaccompanied by :
  • rash
  • swelling
  • fever
  • headache
  • nausea
  • vomiting

Unless directed by a doctor do not administer to children under 3 years of age.

If used for sore mouth:

See your dentist or doctor promptly if

  • sore mouth symptoms do not improve in 7 days.
  • irritation, pain, or redness persists or worsens

Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

Otc Purpose Section (OTC - PURPOSE SECTION)

Uses

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive ingredients

boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Other information

  • store at 15o-30oC (59o-86oF)

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions

  • Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
  • Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.Children under 6 years of age: consult a dentist or doctor
  • Children under 6 years of age: consult a dentist or doctor

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Drug Facts

Active Ingredient

Phenol 0.6%...............Oral Pain Reliever

Uses

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

Warnings

If used for sore throat:

Consult a doctor promplty if sore throat is

  • severe or persists more than 2 days
  • accompanied by :
  • rash
  • swelling
  • fever
  • headache
  • nausea
  • vomiting

Unless directed by a doctor do not administer to children under 3 years of age.

If used for sore mouth:

See your dentist or doctor promptly if

  • sore mouth symptoms do not improve in 7 days.
  • irritation, pain, or redness persists or worsens

Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

Keep out of reech of children.

If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
  • Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.
  • Children under 6 years of age: consult a dentist or doctor

Other information

  • store at 15o-30oC (59o-86oF)

Inactive ingredients

boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reech of children.

If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.


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