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NDC 12258-0223-05 Curasore 1 g/100mL Details

Curasore 1 g/100mL

Curasore is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by S.S.S. Company. The primary component is PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 12258-0223-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	12258-0223
Product ID	12258-223_b3493419-5f78-0390-e053-2995a90a8ac1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Curasore
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pramoxine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100mL
Substance Name	PRAMOXINE HYDROCHLORIDE
Labeler Name	S.S.S. Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 12258-0223-05 (12258022305)

Pricing Information	N/A
NDC Package Code	12258-223-05
Billing NDC	12258022305
Package	1 BOTTLE in 1 CARTON (12258-223-05) / 15 mL in 1 BOTTLE
Marketing Start Date	1995-08-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6891e5aa-e6f2-4355-8ee9-d23c9959787e Details

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

INGREDIENTS AND APPEARANCE

CURASORE

pramoxine hydrochloride liquid

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/31/1995

Labeler - S.S.S. Company (003288321)

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

Revised: 11/2020

Document Id: b3493419-5f78-0390-e053-2995a90a8ac1

Set id: 6891e5aa-e6f2-4355-8ee9-d23c9959787e

Version: 5

Effective Time: 20201104