ORAJEL INSTANT PAIN RELIEF MAXIMUM STRENGTH- benzocaine gel

Orajel Instant Pain Relief by

Drug Labeling and Warnings

Orajel Instant Pain Relief by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                  
Benzalkonium chloride 0.02%           
Benzocaine 20%                             
Zinc chloride 0.1%                          

Purpose

Purpose
Oral antiseptic
Oral pain reliever
Pral astringent

INDICATIONS & USAGE

Use    for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums. To help protect against infection in 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, benzcaine or other "caine" anesthetics

Do not use
more than is directed
for more than 7 days unless directed by a dentist or doctor

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

Keep out of reach of children.   In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions    cut open tip of tube on score mark,  do not use if tube tip is cut prior to opening

Adults and children 2 years of age and over             Apply to affected are up to 4 times daily or as directed by dentist or doctor.

Children under 12 years of age                                Should be supervised in the use of the product

Children under 2 years of age                                  Ask a dentist or doctor

INACTIVE INGREDIENT

Inactive ingredients allantoin, carbomer, edetate disodiu, mentha piperota (peppermint) oil, polyethylene glycol, polysorbate 60, propylene glycol, propyl gallate, purified water, pvp, sodium saccharin, sorbic acid, stearyl alcohol

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

Principal Display - carton

TRIPLE MEDICATED for FAST
EFFECTIVE RELIEF  
               
Orajel                  gel
Instant Pain Relief
For all Mouth Sores

MAXIMUM STRENGTH

SAFETY SEALED TUBE TIP
NET WT 0.125 OZ (3.5g)            ORAL PAIN RELIEVER / ORAL ANTISEPTIC / ORAL ASTRINGENT

carton image

INGREDIENTS AND APPEARANCE

ORAJEL INSTANT PAIN RELIEF  MAXIMUM STRENGTH
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.4 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC - UNII:J41CSQ7QDS)	ZINC CHLORIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER 934 (UNII: Z135WT9208)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
POVIDONE K30 (UNII: U725QWY32X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-708-42	1 in 1 CARTON
1		11.9 g in 1 TUBE
2	NDC: 10237-708-18	1 in 1 CARTON
2		5.1 g in 1 TUBE
3	NDC: 10237-708-12	1 in 1 CARTON
3		3.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/11/2010

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture