ALPHA-CAINE TOPICAL ANESTHETIC- benzocaine gel 
Dental Technologies, Inc.

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Alpha-Caine Drug Facts, Mint

Active ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

For the temporary relief of occasional minor irritation and pain, associated with:

Warnings

For external use only

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 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:

Allergy alert:

Do not use if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

Do not use

When using this product

avoid contact with eyes

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

do not exceed recommended dosage.

Other information

Store at 59° to 86º F (15º to 30º C)

Inactive ingredients

Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*

*contains one or more of these ingredients.

Questions or comments?

1-800-835-0885 or 1-847-677-5500 M-F 8:00 a.m. – 4:30 p.m. CST.

Visit www.dentaltech.com

Principal Display Panel

DENTAL

TECHNOLOGIES

www.dentaltech.com

ALPHA-CAINE

TOPICAL ANESTHETIC GEL

DENTAL TECHNOLOGIES, INC.

Lincolnwood, IL 60712

Made in U.S.A.

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

20% Benzocaine Oral Anesthetic

1oz. (30g)

Alpha-Caine_Mint_image.jpg

ALPHA-CAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-2902
Route of AdministrationPERIODONTAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55346-2902-130 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02212/31/1999
Labeler - Dental Technologies, Inc. (148312838)
Registrant - Dental Technologies, Inc. (148312838)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies, Inc.148312838manufacture(55346-2902) , pack(55346-2902) , label(55346-2902)

Revised: 11/2023
Document Id: 0a96438c-7340-8bce-e063-6394a90a0ce7
Set id: ae628766-25b7-4b4f-abb8-a43faf2f44b9
Version: 8
Effective Time: 20231120
 
Dental Technologies, Inc.