SEVERE ORAL PAIN RELIEVER- benzocaine liquid
CVS Pharmacy

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.

----------

CVS Max Str Oral Pain Reliever Severe

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to toothaches

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 flame or fire. Avoid smoking during application and until product has dried

Stop use and ask a doctor

if swelling, rash or fever develops
irritation, pain or redness persists or worsens

Do not use

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

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

Directions

do not use if package has been opened
adults and children 2 years of age and older: using applicator tip, apply to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. Children 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

This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continiously.

Inactive ingredients

Ethyl Alcohol 44.2% by weight, Red 40, Yellow 5, Flavor, Polyethylene Glycol, Water, Sodium Saccharin

carton label

SEVERE ORAL PAIN RELIEVER
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-820
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	41.99 g in 100 g
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	34.5 g in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.5 g in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.001 g in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.002 g in 100 g
WATER (UNII: 059QF0KO0R)	2.507 g in 100 g

Product Characteristics
Color	orange (orange to reddish orange)	Score
Shape		Size
Flavor	COCONUT (Pina Colada Flavor #26041)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-820-31	1 in 1 CARTON	12/27/2011	02/14/2019
1	NDC:59779-820-39	14.17 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	12/27/2011	02/14/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead (126440440)

Name	Address	ID/FEI	Business Operations
Establishment
CSR Cosmetic Solutions		243501959	manufacture(59779-820)

Revised: 2/2019

Document Id: 81e0c804-de70-0c48-e053-2991aa0a0f72

Set id: a87ae6a3-0c00-4d2c-9663-50cb600526a2

Version: 6

Effective Time: 20190214

CVS Pharmacy