RITE AID LIQUID ANESTHETIC ORAL PAIN RELIEF- benzocaine gel

Rite Aid Liquid Anesthetic Oral Pain Relief by

Drug Labeling and Warnings

Rite Aid Liquid Anesthetic Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

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

PURPOSE

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

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.

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID LIQUID ANESTHETIC ORAL PAIN RELIEF 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3950
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3950-6	1 in 1 CARTON
1		30 mL in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part356	07/08/2010

Labeler - Rite Aid Corporation (014578892)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture