Curasore Liquid
FDA Label NDC 12258-223

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by S.s.s. Company for the product Curasore (NDC 12258-223). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient:, purpose:, uses, warnings, when using this product, otc - stop use, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient:

→ Purpose:

→ Uses

→ Warnings

→ When Using This Product

→ Otc - Stop Use

→ Keep Out Of The Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Other

DRUG FACTS

Active Ingredient:

Pramoxine Hydrochloride 1%

Purpose:

Local Anesthetic

Uses

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

Warnings

For external use only

When Using This Product

Do not swallow
Avoid contact with the eyes
Avoid contact with the nose

Otc - Stop Use

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.

Keep Out Of The Reach Of Children

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

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.

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