DOLLAR GENERAL HEALTH ORAL PAIN RELIEVER- benzocaine gel

Dollar General Health Oral Pain Reliever by

Drug Labeling and Warnings

Dollar General Health Oral Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Dolgencorp LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                           Purpose

Benzocaine 20%......................................................... Oral Pain Reliever

PURPOSE

Uses

for the temporary relief of pain due to toothaches

WARNINGS

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

Do not use

• more than directed
• for more than 7 days unless told to do so by a dentist or doctor

STOP USE

Stop use and ask a doctor if

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• symptoms do not get better in 7 days

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 immediately

INDICATIONS & USAGE

Directions

• remove cap and cut tip on score mark
• adults and children 2 years of age and older: apply a small amount of product to cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist.
• children under 12 years of age: should be supervised in the use of this product
• children under 2 years of age: ask a doctor or dentist

STORAGE AND HANDLING

Other information

• store at 15° to 25°C (59° to 77°)
• do not use if tube tip is cut prior to opening
• this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
• do not use continusly
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ignredients

glycerin, mint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLLAR GENERAL HEALTH ORAL PAIN RELIEVER 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-568
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE HYDROCHLORIDE (UNII: OG625Z9LEO) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE HYDROCHLORIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-568-33	1 in 1 CARTON	10/04/2016
1		9.35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/08/2015

Labeler - Dolgencorp LLC (068331990)