CURASORE- pramoxine hydrochloride liquid

Curasore by

Drug Labeling and Warnings

Curasore by is a Otc medication manufactured, distributed, or labeled by S.S.S. Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

Other Packaging Content

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

ssspharmaceuticals.com

Rev. E

INGREDIENTS AND APPEARANCE

CURASORE 
pramoxine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12258-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ETHER (UNII: 0F5N573A2Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12258-223-05	1 in 1 CARTON	08/31/1995
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/31/1995

Labeler - S.S.S. Company (003288321)

Establishment
Name	Address	ID/FEI	Business Operations
S.S.S. Company		003288321	manufacture(12258-223) , pack(12258-223) , label(12258-223)