ORAL ANALGESIC- benzocaine liquid

Oral Analgesic by

Drug Labeling and Warnings

Oral Analgesic by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution Inc., Church & Dwight Co., Inc., Accupac. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

Uses   temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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.

Flammable:  keep away from fire or flame. Avoid smoking during applications and until product has dried.

When using this product avoid contact with the eyes, do not use more than 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; irritation, pain or redness persists or worsens; swelling, rash or fever develops;

Keep out of reach of children:

in case of overdose, get medical help or contact a Poison Control Center right away

Directions

Directions   remove imprinted safety seal from bottle cap

Adults and children 2 years of age and over                  Apply product with cotton swab or clean fingertip to the affected area.
                                                                                 Use up to 4 times daily or as directed by a dentist or doctor

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

Children under 2 years of age                                       Ask a dentist or doctor



Other information do not use if imprinted bottle seal is broken or missing prior to opening

Inactive ingredients

Inactive ingredients  ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

QUESTIONS

Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm ET

PRINCIPAL DISPLAY PANEL

Meijer

Oral Analgesic Liquid
maximum strength benzocaine 20%

For Fast Relief of Oral Pain Caused by:
Toothache, Denture or Gum Irritations,
Cold or Canker Sores

Oral Analgesic Liquid
maximum Strength
safety sealed tube tip

NET WT. 0.45 OZ (13.3g)

Carton Image

INGREDIENTS AND APPEARANCE

ORAL ANALGESIC   MAXIMUM STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	0.2 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-703-45	1 in 1 CARTON
1		13.3 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/13/2010

Labeler - Meijer Distribution Inc. (006959555)

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

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	manufacture