Septocaine (Page 4 of 4)

MAXIMUM RECOMMENDED DOSAGES

Adults

For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg) or 3.2 mg/lb (0.0795 mL/lb) of body weight.

Pediatric Patients

Use in pediatric patients under 4 years of age is not recommended. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. Do not exceed the equivalent of 7 mg/kg (0.175 mL/kg) or 3.2 mg/lb (0.0795 mL/lb) of body weight.

STERILIZATION, STORAGE, AND TECHNICAL PROCEDURES

For chemical disinfection of the carpule, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Septocaine® (articaine HCl 4% with epinephrine 1:100,000 Injection) is available in 1.7 mL glass cartridges, in boxes or cans of 50 cartridges. The product is formulated with a 15% overage of epinephrine.

NDC 12862-1050-1 Can of 50 cartridges
NDC 12862-1050-2 Box of 50 cartridges

Store at 25°C (77°F) with brief excursions permitted between 15° and 30°C (59°F-86°F) (see USP controlled room temperature). Protect from light.

Manufactured in France by : SEPTODONT, France.

Distributed by : SEPTODONT, Inc.,
245, Quigley Boulevard-Suite C
New Castle, Delaware 19720

® 05 14 228 50 03
02/02

SEPTOCAINE
articaine hydrochloride and epinephrine bitartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12862-1050
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Articaine Hydrochloride (articaine) articaine 40 mg in 1 mL
Epinephrine bitartrate (epinephrine) epinephrine 10 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 1.6 mg in 1 mL
Sodium metabisulfite 0.5 mg in 1 mL
Sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12862-1050-1 50 CARTRIDGE (50 CARTRIDGE) in 1 CAN contains a CARTRIDGE
1 1.7 mL (1.7 MILLILITER) in 1 CARTRIDGE This package is contained within the CAN (12862-1050-1)
2 NDC:12862-1050-2 50 CARTRIDGE (50 CARTRIDGE) in 1 BOX contains a CARTRIDGE
2 1.7 mL (1.7 MILLILITER) in 1 CARTRIDGE This package is contained within the BOX (12862-1050-2)
Labeler — SEPTODONT, Inc.

Revised: 12/2006 SEPTODONT, Inc.

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