N'ice Sore Throat Honey Lemon

N'ice Sore Throat Honey Lemon
SPL v3
SPL
SPL Set ID 601aea98-e6ab-de6f-e053-2a91aa0a824a
Route
ORAL
Published
Effective Date 2014-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
Glycerin Propylene Glycol Saccharin Water Sodium Citrate Citric Acid Monohydrate Polysorbate 80 Food Yellow 3 Free Acid Caramel Triacetin

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-07

Description

Active Ingredients Purposes Phenol 1.4% Oral Anesthetic/Analgesic


Medication Information

Description

Active Ingredients Purposes Phenol 1.4% Oral Anesthetic/Analgesic

Uses

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

Section 55105-1
Active Ingredients Purposes
Phenol 1.4% Oral Anesthetic/Analgesic
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 doctor.

Directions
  • apply to the affected area
  • 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

age dose
adults and children 12 years of age and older for each application, spray 5 times
children 3 to under 12 years

should be supervised in use of this product

for each application, spray 3 times

children under 3 years of age consult a doctor or dentist

Questions?

1-855-452-9500or email at [email protected]

Distributed By:

LEOSONS

Albany, New York 12205

Made in USA

Tamper Evident:

DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Other Information
  • store at room temperature
Inactive Ingredients

caramel color, citric acid, FD&C yellow #6, flavor, glycerin, polysorbate 80, propylene glycol, sodium citrate, sodium saccharin, triacetin, and water

Principal Display Panel

SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE

N'ICE®

P H E N O L / O R A L A N E S T H E T I C

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

HONEY LEMON FLAVOR

6 FL OZ (177 mL)

When Using This Product

do not use more than 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 occurs
If Pregnant Or Breast Feeding,

ask a health professional before use.

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.


Structured Label Content

Uses

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

Section 55105-1 (55105-1)
Active Ingredients Purposes
Phenol 1.4% Oral Anesthetic/Analgesic
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 doctor.

Directions
  • apply to the affected area
  • 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

age dose
adults and children 12 years of age and older for each application, spray 5 times
children 3 to under 12 years

should be supervised in use of this product

for each application, spray 3 times

children under 3 years of age consult a doctor or dentist

Questions? (QUESTIONS?)

1-855-452-9500or email at [email protected]

Distributed By: (Distributed by:)

LEOSONS

Albany, New York 12205

Made in USA

Tamper Evident:

DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Other Information
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

caramel color, citric acid, FD&C yellow #6, flavor, glycerin, polysorbate 80, propylene glycol, sodium citrate, sodium saccharin, triacetin, and water

Principal Display Panel

SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE

N'ICE®

P H E N O L / O R A L A N E S T H E T I C

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

HONEY LEMON FLAVOR

6 FL OZ (177 mL)

When Using This Product (When using this product)

do not use more than directed.

Stop Use and Ask A Doctor If (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 occurs
If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Keep This and All Drugs Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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