Topcare Sore Throat Spray Sugar Free

Topcare Sore Throat Spray Sugar Free
SPL v6
SPL
SPL Set ID fb1f2c11-2508-4985-bae5-7d547bd6aa23
Route
ORAL
Published
Effective Date 2019-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
Fd&c Green No. 3 D&c Green No. 5 D&c Yellow No. 10 Glycerin Water Sucralose

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-06

Description

Phenol 1.4%

Purpose

Oral anesthetic/analgesic


Medication Information

Purpose

Oral anesthetic/analgesic

Description

Phenol 1.4%

Uses

For the temporarily relieves 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 a doctor promptly. Do not use more than 2 days or administer to children under 6 year of age unless directed by doctor.

Directions
  • Adults and children 12 year of age and older:

Apply to 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 use of this product.
  • Children under 6 years of age: Ask a doctor or dentist
Active Ingredient

Phenol 1.4%

Other Information
  • store at room temperature
  • Check expiration date before using.
Inactive Ingredients

FD&C Green No.3, D&C Green No. 5, D&C Yellow No.10, flavor, glycerin, purified water, sucralose.

Questions Or Comments?

1-888-423-0139

Principal Display Panel

TopCare ®health

NDC# 36800-606-06

COMPARE TO THE CHLORASEPTIC® ACTIVE INGREDIENT*

SUGAR FREE

Sore Throat Spray

PHENOL / ORAL ANESTHETIC

  • Works on Contact
  • Relieves Sore Throat Pain
  • Fast Acting

ASPIRIN FREE

ALCOHOL FREE

MENTHOL FLAVOR

OUR PHARMACIST RECOMMEND

6 FL OZ (177 mL)

QUALITY GUARANTEED

*This product is not manufactured or distributed by Prestige Brands Co., distributor of Chloraseptic®.

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

DISTRIBUTED BY TOPCO ASSOCIATESLLC,

ELK GROVE VILLAGE, IL 6007

TOPCO RARA1217

QUESTIONS? 1-888-423-0139

[email protected] www.tocarebrand.com

When Using This Product,

do not exceed recommended dosage.

If Pregnant Or Breast Feeding,

ask a doctor before use.

Keep Out of Reach of Children.

In case of overdose or accidental,get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

Structured Label Content

Uses

For the temporarily relieves of occasional minor irritation, pain, sore mouth and sore throat.

Purpose

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 a doctor promptly. Do not use more than 2 days or administer to children under 6 year of age unless directed by doctor.

Directions
  • Adults and children 12 year of age and older:

Apply to 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 use of this product.
  • Children under 6 years of age: Ask a doctor or dentist
Active Ingredient (Active ingredient)

Phenol 1.4%

Other Information (Other information)
  • store at room temperature
  • Check expiration date before using.
Inactive Ingredients (Inactive ingredients)

FD&C Green No.3, D&C Green No. 5, D&C Yellow No.10, flavor, glycerin, purified water, sucralose.

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel

TopCare ®health

NDC# 36800-606-06

COMPARE TO THE CHLORASEPTIC® ACTIVE INGREDIENT*

SUGAR FREE

Sore Throat Spray

PHENOL / ORAL ANESTHETIC

  • Works on Contact
  • Relieves Sore Throat Pain
  • Fast Acting

ASPIRIN FREE

ALCOHOL FREE

MENTHOL FLAVOR

OUR PHARMACIST RECOMMEND

6 FL OZ (177 mL)

QUALITY GUARANTEED

*This product is not manufactured or distributed by Prestige Brands Co., distributor of Chloraseptic®.

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

DISTRIBUTED BY TOPCO ASSOCIATESLLC,

ELK GROVE VILLAGE, IL 6007

TOPCO RARA1217

QUESTIONS? 1-888-423-0139

[email protected] www.tocarebrand.com

When Using This Product, (When using this product,)

do not exceed recommended dosage.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor before use.

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

In case of overdose or accidental,get medical help or contact a Poison Control Center right away (1-800-222-1222).

Stop Use and Ask A Doctor Or Dentist If (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

Advanced Ingredient Data


Raw Label Data

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