OTC Medication Information: CVS Health Sore Throat Fast Relief Oral Anesthetic

CVS HEALTH SORE THROAT FAST RELIEF ORAL ANESTHETIC- phenol spray
CVS Pharmacy,Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Uses

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

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 6 years of age unless directed by 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 doctor 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 (1-800-222-1222).

Directions

Adults and children 6 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 6 years of age: consult a doctor or dentist

Other information

•

Store at room temperature

•

Check expiration date before using

Inactive ingredients

FD&C Red #40, flavor, glycerin, purified water, sucralose

Questions or comments?

1-866-467-2748

Aspirin-Free● Sugar-Free ●Gluten-Free ●Alcohol-Free

Principal Display Panel

CVS Health_™

*Compare to active ingredient in Chloraseptic^® *

Sore Throat Spray

PHENOL ORAL ANESTHETIC

Fast Relief

•

Fast acting sore throat relief

•

Sugar, gluten & aspirin free

Alcohol-Free

Cherry Flavor

Naturally and Artificially Flavored

6 FL OZ (177 mL)

*This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic^®

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2018 CVS /Pharmacy

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Made in the U.S.A. V-12431

CVS Quality

Money back Guarantee

CVS HEALTH SORE THROAT FAST RELIEF ORAL ANESTHETIC phenol spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-895 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOL (PHENOL) PHENOL 1.4 g in 100 mL

Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 GLYCERIN WATER SUCRALOSE

Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59779-895-06 177 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/18/2015

Labeler — CVS Pharmacy,Inc. (062312574)

Revised: 09/2020 CVS Pharmacy,Inc.