Label: 7 SELECT ORAL PAIN MAXIMUM STRENGTH RELIEF- benzocaine gel
- NDC Code(s): 10202-853-14
- Packager: 7-ELEVEN, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 8, 2016
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
Active ingredient Purpose
Benzocaine 20%.................................Oral Pain relieverClose
Use for the temporary relief of pain due to toothachesClose
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" anestheticsClose
- DO NOT USE
Do not use
- more than directed
- for more than 7 days unless directed 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 improve 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 right away.Close
- INDICATIONS & USAGE
- remove cap and cut tip of tube on score mark
- adults and children 2 years of age and older: 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 doctor.
- children under 12 years of age: should be supervised in the use of this product
- children under 2 years of age: ask a dentist or doctor
- STORAGE AND HANDLING
- store at 15° to 25°C (59° to 77°F)
- 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 or doctor can be consulted
- do not use continuously
- lot no. & exp. date: see package or see crimp of tube
- INACTIVE INGREDIENT
Inactive ingredients glycerin, mint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitolClose
- DOSAGE & ADMINISTRATION
DISTRIBUTED BY 7-ELEVEN, INC.
Irving, TX 75063
Made in KoreaClose
- INGREDIENTS AND APPEARANCE
7 SELECT ORAL PAIN MAXIMUM STRENGTH RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-853 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:10202-853-14 1 in 1 BLISTER PACK 12/08/2016 1 14 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 12/08/2016 Labeler - 7-ELEVEN, INC. (007347602)