SPL v7
SPL
SPL Set ID 6891e5aa-e6f2-4355-8ee9-d23c9959787e
Route
TOPICAL
Published
Effective Date 2014-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g)
Inactive Ingredients
Alcohol Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1995-08-31

Description

DRUG FACTS

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

DRUG FACTS

Uses

For the temporary relief of pain and itching associated with fever blisters and cold sores

Section 42229-5

DRUG FACTS

Section 50566-9

Stop use and consult a doctor If

  • Redness
  • Swelling
  • Irritation or pain persists or increases, condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Purpose:

Local Anesthetic

Warnings

For external use only

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily; avoid moistening area for 2 to 3 minutes following application. Children under 2 years of age: consult a doctor.

Other Information
  • FLAMMABLE
  • Keep away from heat, sparks, and open flame
  • Store in a cool place
  • Keep lid tightly capped.
  • To report an adverse event or obtain product information contact (404) 521-0857.
Active Ingredient:

Pramoxine Hydrochloride 1%

Inactive Ingredients

ethyl alcohol and ethyl ether

Principal Display Panel

NDC 12258-223-05

CURASORE®

Pain Relieving Anesthetic for

Fever Blisters • Cold Sores

Contains Ether

0.5 FL OZ (15mL)

Important: Begin application at the

first sign of a fever blister or cold

sore.

CURASORE®

Analgesic-Anesthetic-Antipruritic

for Relieving Pain & Itching of

Fever Blisters & Cold Sores

With

DISPOSABLE COTTON APPLICATORS

Other Packaging Content

Manufactured by S.S.S. Company, Atlanta, GA 30315, USA

ssspharmaceuticals.com

Rev. E

When Using This Product
  • Do not swallow
  • Avoid contact with the eyes
  • Avoid contact with the nose
Keep Out of the Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

For the temporary relief of pain and itching associated with fever blisters and cold sores

Section 42229-5 (42229-5)

DRUG FACTS

Section 50566-9 (50566-9)

Stop use and consult a doctor If

  • Redness
  • Swelling
  • Irritation or pain persists or increases, condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Purpose:

Local Anesthetic

Warnings

For external use only

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily; avoid moistening area for 2 to 3 minutes following application. Children under 2 years of age: consult a doctor.

Other Information
  • FLAMMABLE
  • Keep away from heat, sparks, and open flame
  • Store in a cool place
  • Keep lid tightly capped.
  • To report an adverse event or obtain product information contact (404) 521-0857.
Active Ingredient:

Pramoxine Hydrochloride 1%

Inactive Ingredients

ethyl alcohol and ethyl ether

Principal Display Panel

NDC 12258-223-05

CURASORE®

Pain Relieving Anesthetic for

Fever Blisters • Cold Sores

Contains Ether

0.5 FL OZ (15mL)

Important: Begin application at the

first sign of a fever blister or cold

sore.

CURASORE®

Analgesic-Anesthetic-Antipruritic

for Relieving Pain & Itching of

Fever Blisters & Cold Sores

With

DISPOSABLE COTTON APPLICATORS

Other Packaging Content

Manufactured by S.S.S. Company, Atlanta, GA 30315, USA

ssspharmaceuticals.com

Rev. E

When Using This Product (When using this product)
  • Do not swallow
  • Avoid contact with the eyes
  • Avoid contact with the nose
Keep Out of the Reach of Children (Keep out of the reach of children)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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