ORAJEL TOOTHACHE STRIPS- benzocaine, menthol film, soluble
BioFilm Limited

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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Orajel Toothache Strips

Drug Facts

Active ingredients

Benzocaine 15 mg

Menthol 5 mg

Purpose

Oral pain reliever

Use

for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

Warnings

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine 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 of fever develops
irritation, pain or reness persists or worsens
symptoms do not improve in 7 days
allergic reaction occurs

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

make sure hands are dry and free of moisture
tear open puch and remove blue stip
strips are desinged to work on either side


Adults and children 12 years of age and over	Using either side of stip, place onto the affected area and gently press for 5-10 seconds until stip adheres to the area Stip will stay in place and dissolve slowly in mouth up to 1 hour for duration of treatment Use up to 4 times daily or as direcred by a physician or healthcare provider
Children under 12 years of age	Ask a physician or healthcare provider

Other information

do not use if pouch is torn or cut prior to opening
do not use continuously
for best results, avoid drinking warm beverages or eating for at least one hour after applying the product

Inactive ingredients

acid blue 9, glycerin PEG-8, PEG-90, polycarbophil, potassium sorbate, pullulan, PVP, titanium dioxide, water. Formula subject to change.

Questions or comments?

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

Package Labeling:

Label Label2

ORAJEL TOOTHACHE STRIPS
benzocaine, menthol film, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72337-000
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POLYCARBOPHIL (UNII: W25LM17A4W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PULLULAN (UNII: 8ZQ0AYU1TT)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72337-000-00	8 in 1 BOX	01/01/2018	01/01/2018
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/01/2018	01/01/2018

Labeler - BioFilm Limited (734555951)

Revised: 12/2018

Document Id: 7c36fc05-5242-74b5-e053-2991aa0a4e6d

Set id: 6e10252c-3c52-7231-e053-2991aa0a2502

Version: 2

Effective Time: 20181204

BioFilm Limited