Label: ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL COOL MINT- benzocaine, butamben, tetracaine hydrochloride gel
Contains inactivated NDC Code(s)
NDC Code(s): 62565-901-01
- Packager: HAGER WORLDWIDE, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 16, 2011
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PRINCIPAL DISPLAY PANEL
Caution: Rx Only.
Do not use in eyes. Keep out of reach of children.
Directions: Read package insert.
Press top of container to dispense desired amount.
Dispense 200 mg of gel (a bead approximately
1/4 to 1/2 inches long) by gently depressing the
pump. Dispensing a bead in excess of 400 mg is
contraindicated. Spread thinly and evenly over the
desired area using a cotton swab.
Active Ingredients: Benzocaine 14.0%,
Butamben 2.0%, Tetracaine Hydrochloride 2.0%
Inactive Ingredients: Benzalkonium Chloride
0.5%, Cetyl Dimethyl Ethyl Ammonium Bromide
0.005%, in a bland water-soluble base.
Topical Anesthetic Gel
is indicated for anesthesia of
accessible mucous membrane.
Net Wt. 32 g
Store in a cool dry place.
Odessa, FL 33556 USA
Made in U.S.A. Rev. 05/09
- INACTIVE INGREDIENT
MECHANISM OF ACTION
The onset of OneTouch Advanced-produced anesthesia is rapid (approximately
30 seconds) and the duration of anesthesia is typically 30-60 minutes, when
used as directed. This effect is due to the rapid onset, but short duration of
action of Benzocaine coupled with the slow onset, but extended duration of
Tetracaine HCI and bridged by the intermediate action of Butamben.
It is believed that all of these agents act by reversibly blocking nerve conduc-
tion. Speed and duration of action is determined by the ability of the agent to
be absorbed by the mucous membrane and nerve sheath and then to diffuse
out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert
metabolites which are excreted in the urine.
- INDICATIONS & USAGE
DOSAGE & ADMINISTRATION
Dosage and Administration
Only a limited quantity is OneTouch Advanced Gel is required for anesthesia.
Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently
depressing the pump. Dispensing a bead of gel in excess of 400 mg is contrain-
dicated. Spread thinly and evenly over the desired area using a cotton swab.
An appropriate pediatric dosage has not been established for OneTouch Ad-
Dosages should be reduced in the debilitated elderly, acutely ill, and very young
Tissue need not be dried prior to application of OneTouch Advanced Gel. One-
Touch Advanced Gel should be applied directly to the site where pain control is
required. Anesthesia is produced within one minute with an approximate duration
of thirty minutes. Each 200 mg dose of OneTouch Advanced Gel contains 28 mg
of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCI.
Hypersensitivity Reactions: Unpredictable adverse reactions (i.e. hypersensi-
tivity, including anaphylaxis) are extremely rare.
Localized allergic reactions may occur after prolonged or repeated use of any
aminobenzoate anesthetic. The most common adverse reaction caused by
local anesthetics is contact dermatitis characterized by erythema and pruritus
that may progress to vesiculation and oozing. This occurs most commonly in
patients following prolonged self-medication, which is contraindicated. If rash,
urticaria, edema, or other manifestations of allergy develop during use, the drug
should be discontinued. To minimize the possibility of a serious allergic reaction,
OneTouch Advanced Gel should not be applied for prolonged periods except
under continual supervision. Dehydration of the epithelium or an escharotic ef-
fect may also result from prolonged contact.
Precaution: On rare occasions, methemoglobinemia has been reported in
connection with the use of benzocaine-containing products. Care should be
used not to exceed the maximum recommended dosage (see Dosage and
Administration). If a patient becomes cyanotic, treat appropriately to counteract
(such as with methylene blue, if medically indicated).
Use in Pregnancy: Safe use of One Touch Advanced Gel has not been
established with respect to possible adverse effects upon fetal development.
Therefore, OneTouch Advanced Gel should not be used during early pregnancy,
unless in the judgement of a physician, the potential benefits outweigh the un-
known hazards. Routine precaution for the use of any topical anesthetic should
be observed when OneTouch Advanced Gel is used.
OneTouch Advanced Gel is not suitable and should never be used for injection.
Do not use on the eyes. To avoid excessive systemic absorption, OneTouch
Advanced Gel should not be applied to large areas of denuded or inflamed
tissue. OneTouch Advanced Gel should not be administered to patients who are
hypersensitive to any of its ingredients or to patients known to have cholinest-
erase deficiencies. Tolerance may vary with status of the patient.
OneTouch Advanced Gel should not be used under dentures or cotton rolls, as
retention of the active gel ingredients under a denture or cotton roll could pos-
sibly cause an escharotic effect. Routine precaution for the use of any topical
anesthetic should be observed when using OneTouch Advanced Gel.
- HOW SUPPLIED
INGREDIENTS AND APPEARANCE
ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL COOL MINT
benzocaine, butamben, tetracaine hydrochloride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62565-901 Route of Administration TOPICAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 28 mg in .2 g BUTAMBEN (UNII: EFW857872Q) (BUTAMBEN - UNII:EFW857872Q) BUTAMBEN 4 mg in .2 g TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE 4 mg in .2 g Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 1 mg in .2 g Product Characteristics Color green (GREEN) Score Shape Size Flavor MINT (COOL MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62565-901-01 1 in 1 BOX 1 32 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2009 Labeler - HAGER WORLDWIDE, INC. (009277971) Registrant - HAGER WORLDWIDE, INC. (009277971) Establishment Name Address ID/FEI Business Operations HAGER WORLDWIDE, INC. 009277971 manufacture