Rite Aid Liquid Anesthetic Oral Pain Relief

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1mL
Labeler: Rite Aid Corporation
NDC Code: 11822-3950

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.

drug facts

Active ingredient                                 Purpose

Benzocaine, 20%............................................Anesthetic



Uses

- temporary relieves pain associated with:      - canker sores
- minor irritation or injury of mouth and gums  - minor dental procedures
- minor irritation of mouth and gums caused by dentures or orthodontic appliances

also for the temporary relief of sore gums due to teething in children 2 years of age and older


Keep out of reach of children. If more than is used for oral anesthetic is accidentally
swallowed, get medical help or contact a Poison Control Center right away.


Uses

- temporary relieves pain associated with:      - canker sores
- minor irritation or injury of mouth and gums  - minor dental procedures
- minor irritation of mouth and gums caused by dentures or orthodontic appliances

also for the temporary relief of sore gums due to teething in children 2 years of age and older
 


Warnings

Fever and nasal congestion are not symptoms of teething and may indicate the presence
of infection. If these symptoms persist, contact your doctor.

Do not use - for more than directed - for more than 7 days, unless directed by a dentist or doctor
-  if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or
other "caine" anesthetics

When using this product
- avoid contact with the eyes - do not exceed recommended dosage

Stop use and ask a doctor if:

- sore mouth symptoms do not improve in 7 days
- swelling, rash or fever develops  - irritation, pain or redness persists or worsens

Keep out of reach of children.
If more then used for oral anesthetic is accidentally swallowed,
get medical help or contact a Poison Control Center right away.


Directions Adults and children 2 years of age and older

- apply to the affected area  - allow to remain in place at least 1 minute and then spit out
- use up to four times a day or as directed by a dentist or doctor

For teething apply to affected area not more than 4 times dialy, or as directed by a dentist or doctor

Children under 2 years of age consult a dentist or doctor
Children under 12 years of age should be supervised in the use of this product


Inactive Ingredients

PEG-8, propylene glycol, flavor, benzyl alcohol, methylparaben, saccharin, red 40, yellow 10, blue 1




RITE AID LIQUID ANESTHETIC ORAL PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3950
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
SPEARMINT OIL 
PEPPERMINT OIL 
METHYLPARABEN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SACCHARIN 
Packaging
#Item CodePackage Description
1NDC:11822-3950-61 TUBE, WITH APPLICATOR (TUBE) in 1 CARTON
130 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35607/08/2010
Labeler - Rite Aid Corporation (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 07/2010
 
Rite Aid Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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