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NDC 00699-3100-02 Topex 220 mg/g Details

Topex 220 mg/g

Topex is a PERIODONTAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dentsply LLC. Professional Division Trading as "Sultan Healthcare". The primary component is BENZOCAINE.

Product Information

NDC	00699-3100
Product ID	0699-3100_015b2c83-52fd-4360-a252-90674052adaf
Associated GPIs	88350010003240
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	Topex
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzocaine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SPRAY, METERED
Route	PERIODONTAL
Active Ingredient Strength	220
Active Ingredient Units	mg/g
Substance Name	BENZOCAINE
Labeler Name	Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00699-3100-02 (00699310002)

Pricing Information	N/A
NDC Package Code	0699-3100-02
Billing NDC	00699310002
Package	1 CANISTER in 1 CARTON (0699-3100-02) / 57 g in 1 CANISTER
Marketing Start Date	1974-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60c87af2-1dc5-2daf-e053-2a91aa0a7555 Details

INDICATIONS AND USAGE

Topical anesthetic for use on oral mucosa

DOSAGE AND ADMINISTRATION

Attach disposable straw to the spray valve. Spray directly on mucosa to achieve topical anesthesia.

DOSAGE FORMS AND STRENGTHS

Each gram of Topex 20% benzocaine topical anesthetic spray contains between 180-220 mg benzocaine. Each metered spray delivers approximately 6.8 mg of benzocaine.

CONTRAINDICATIONS

Should not be used in individuals with a known sensitivity to benzocaine or PABA.

WARNINGS AND PRECAUTIONS

METHEMOGLOBINEMIA WARNING:

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:

pale, gray, or blue colored skin (cyanosis),
headache,
rapid heart rate,
shortness of breath,
dizziness or lightheadedness,
fatigue or lack of energy

• Not for use in children under 2 years of age.

• Keep out of reach of children.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

STORAGE AND HANDLING

Store between 59°-86°F (15°-30°C).

PRINCIPAL DISPLAY PANEL - Carton

INGREDIENTS AND APPEARANCE

TOPEX

benzocaine spray, metered

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0699-3100
Route of Administration	PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BENZALDEHYDE (UNII: TA269SD04T)
APAFLURANE (UNII: R40P36GDK6)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0699-3100-02	1 in 1 CARTON	01/01/1974
1		57 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		01/01/1974

Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)

Name	Address	ID/FEI	Business Operations
Establishment
Sciarra Laboratories, Inc.		824900369	MANUFACTURE(0699-3100)

Revised: 1/2022

Document Id: 015b2c83-52fd-4360-a252-90674052adaf

Set id: 60c87af2-1dc5-2daf-e053-2a91aa0a7555

Version: 2

Effective Time: 20220118