RITE AID ORAL PAIN RELIEVER- benzocaine liquid 
Rite Aid

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.

----------

Rite Aid Max Str Oral Pain Relief Liquid

Active ingredient

Benzocaine 20.0%  ...................................................................... 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

• 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 (68-77F)

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

bottle label

blister label

RITE AID  ORAL PAIN RELIEVER
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5334
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ALCOHOL (UNII: 3K9958V90M)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colororange (orange to reddish orange) Score    
ShapeSize
FlavorMINT (N&A Mint Flavor 619179) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-5334-81 in 1 BLISTER PACK08/01/201303/02/2019
1NDC:11822-5334-114.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/01/201303/02/2019
Labeler - Rite Aid (014578892)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions243501959manufacture(11822-5334) , pack(11822-5334)

Revised: 3/2019
 
Rite Aid