LUCKY ORAL PAIN RELIEF- benzocaine benzalkonium chloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Delta Brands Inc

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 20 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral pain reliever Antiseptic ■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider ■ swelling, rash or fever develops ■ irritation, pain or redness persists or worsens ■ symptoms do not improve in 7 days

Authorization status:

OTC monograph not final

Summary of Product characteristics

LUCKY ORAL PAIN RELIEF- BENZOCAINE BENZALKONIUM CHLORIDE GEL
DELTA BRANDS INC
_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._
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LUCKY ORALGEL
_ACTIVE INGREDIENT_
Benzocaine 20%
Benzalkonium Chloride 0.1%
_PURPOSE_
Oral pain reliever
Antiseptic
_USE_
■ for the temporary relief of pain due to toothaches ■ to help
protect against
infectionin minor oral irritation
_WARNINGS_
■ ALLERGY ALERT: do not use this product if you have a history of
allergy to local
anesthetics such as procaine, butacaine or other "caine" anesthetics
DO NOT USE
■ more than directed ■ for more than 7 days unless directed by a
physician or
healthcare provider
STOP USE AND ASK A PHYSICIAN IF
■ swelling, rash or fever develops ■ irritation, pain or redness
persists or worsens ■
symptoms do not improve in 7 days
KEEP OUT OF REACH OF CHILDREN
In case of overdose or allergic reaction get medical help or contact a
Poison Control
Center right away
_DIRECTIONS_
■ adults and children 2 years of age and over: apply a small amount
of the product to
the cavity and around the gum surrounding the teeth Use up to 4 times
daily or as
directed by a physician or healthcare provider ■ children under 12
years: should be
supervised in the use of this product ■ children under 2 years of
age: ask a physician or
health care provider
_OTHER INFORMATION_
■ this preparation is intended for use in cases ot toothache, only
as a temporary
expedient until a physican can be consulted ■ do not use
continuously ■ avoid using
toothpaste or drinking soft drinks or fruit juices for at least one
hour after applying ■ do
not use if tube seal under cap is broken, missing or if the tube tip
is cut prior to opening
_INACTIVE INGREDIENTS_
ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin,
sorbic acid
PACKAGE LABEL
LUCKY ORAL PAIN RELIEF
benzocaine benzalkonium chloride g