Label: ALPHA-CAINE TOPICAL ANESTHETIC- benzocaine gel
- NDC Code(s): 55346-2902-1
- Packager: Dental Technologies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
If you are a consumer or patient please visit this version.
- Active ingredient
For the temporary relief of occasional minor irritation and pain, associated with:
- Sore mouth and throat
- Minor dental procedures
- Needle punctures
- Minor irritation of the mouth and gums caused by dentures or orthodontic appliances
For external use only
Allergy alert: Do not use if you have a history of allergy to any "caine" anesthetics, such as benzocaine, butacaine, procaine, or tetracaine.Close
- 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.Close
- When using this product
avoid contact with eyesClose
- Stop use and ask a doctor if
you experience any of the following symptoms, as these may be a sign of methemoglobinemia, a rare disorder which can appear up to 2 hours after use:
- pale, gray or blue-colored skin, lips and nail beds
- shortness of breath
- rapid heart rate
If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.Close
- If pregnant or breast-feeding,
ask a health professional before use.Close
- Keep out of reach of children.
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.Close
- do not exceed recommended dosage.
- adults and children 2 years of age and older: Apply to the affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
- children under 12 years of age: Should be supervised in the use of the product.
- children under 2 years of age: Consult a dentist or doctor.
- Other information
Store at 59° to 86º F (15º to 30º C)Close
- Inactive ingredients
Blue 1, flavor, PEG-8, PEG-75, sodium saccharin, Yellow 10Close
- Questions or comments?
1-800-835-0885 or 1-847-677-5500
M-F 8:00 a.m. - 4:30 p.m. CST.
- Principal Display Panel
TOPICAL ANESTHETIC GEL
20% Benzocaine Oral Anesthetic
1 oz. (30g)
- SPL UNCLASSIFIED SECTION
DENTAL TECHNOLOGIES, INC.
Lincolnwood, IL 60712
Made in U.S.A.
DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.Close
- INGREDIENTS AND APPEARANCE
ALPHA-CAINE TOPICAL ANESTHETIC
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55346-2902 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400 Polyethylene Glycol 3350 SACCHARIN SODIUM FD&C BLUE NO. 1 D&C YELLOW NO. 10 Product Characteristics Color Score Shape Size Flavor MINT (Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55346-2902-1 30 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/31/1999 Labeler - Dental Technologies, Inc. (148312838) Registrant - Dental Technologies, Inc. (148312838) Establishment Name Address ID/FEI Business Operations Dental Technologies, Inc. 148312838 manufacture(55346-2902), pack(55346-2902), label(55346-2902)