7 SELECT ORAL PAIN MAXIMUM STRENGTH RELIEF- benzocaine gel 
7-ELEVEN, INC.

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.

----------

7 Select Oral Pain Reliever Max. Strength Gel 0.5oz (58853)

Active ingredient                                 Purpose

Benzocaine 20%.................................Oral Pain reliever

Use for the temporary relief of pain due to:

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate meddical attention if you or a child in your care develops:

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

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 2 years of age and older.Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or dentist.
Children under 12 years of age.Should be supervised in the use of this product.
Children under 2 years of age.Do not use.

Other information

Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DISTRIBUTED BY 7-ELEVEN, INC.

Irving, TX 75063

WWW.7-ELEVEN.COM

58853A

7 SELECT ORAL PAIN MAXIMUM STRENGTH RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10202-853
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
MINT (UNII: FV98Z8GITP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10202-853-141 in 1 BLISTER PACK12/08/2016
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/08/2016
Labeler - 7-ELEVEN, INC. (007347602)

Revised: 12/2022
Document Id: efceca57-21d7-6879-e053-2a95a90a8cbb
Set id: f170a570-1c50-4b9a-be16-9b01bf5eaa74
Version: 5
Effective Time: 20221214
 
7-ELEVEN, INC.