Health-Tec Topical Anesthetic by Dental Health Products, Inc.

Drug Details [pdf]

HEALTH-TEC TOPICAL ANESTHETIC- benzocaine gel
Dental Health Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Benzocaine 200mg (in each g)

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child 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

Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use

for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
for teething
in children under 2 years of age

When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.

Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.
children under 2 years of age: do not use

Keep out of reach of children.

Other Information

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions of comments?

800-626-2163

LB.DHPI_Topical Wrap_R2.jpg

HEALTH-TEC TOPICAL ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69634-024
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	PINEAPPLE (PINA COLADA)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69634-024-30	30 g in 1 JAR; Type 0: Not a Combination Product	07/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	04/01/2015	12/26/2019

Labeler - Dental Health Products, Inc. (623191194)

Revised: 12/2019

Document Id: 9a9d9092-430d-71af-e053-2995a90acd06

Set id: 5eb437c5-a2af-4c0d-b7b9-9ab7d093db85

Version: 4

Effective Time: 20191226