ORAL PAIN RELIEVER- benzocaine liquid
Dolgencorp LLC

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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Rexall Max Str Oral Pain Relief

Active ingredient

Benzocaine 20.0%

Purpose

Oral anesthetic

Use

Temporarily relieves pain associated with the following mouth and gum irritations:

toothache
sore gums
canker sores
braces
minor dental procedures

For oral use only
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
When using this product

avoid contact with eyes
do not exceed recommended dosage
do not use 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

Adults and children 2 years of age and older:

apply to affected area using applicator tip
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: consult a dentist or doctor

Other Information

store at 20 - 25°C (68-77°F)

Inactive ingredients

Ethyl Alcohol 44.2% by weight, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Flavor, Polyethylene glycol, Sodium Saccharin, Water

ORAL PAIN RELIEVER
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-824
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	33.87 g in 100 g
ALCOHOL (UNII: 3K9958V90M)	44.2 g in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.5 g in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.55 g in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.9 g in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.04 g in 100 g
WATER (UNII: 059QF0KO0R)	0.6732 g in 100 g

Product Characteristics
Color	orange (orange to reddish orange)	Score
Shape		Size
Flavor	MINT (N&A Mint Flavor 619179)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55910-824-48	1 in 1 BLISTER PACK	01/10/2012	02/14/2019
1	NDC:55910-824-41	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	01/10/2012	02/14/2019

Labeler - Dolgencorp LLC (068331990)

Registrant - Lornamead (126440440)

Name	Address	ID/FEI	Business Operations
Establishment
CSR Cosmetic Solutions		243501959	manufacture(55910-824)

Revised: 2/2019

Document Id: 81ddb213-0052-98d4-e053-2991aa0af6fa

Set id: 7e5ba057-8d58-4f9c-99e2-7972218d6eba

Version: 2

Effective Time: 20190214

Dolgencorp LLC