Beutlich Pharmaceuticals, 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.


Drug Facts

Active ingredient

Benzocaine 20%


Oral Anesthetic


for the temporary relief of occasional minor irritation and pain associated with:


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 medical attention if you or a child in your care develops:
• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Do not use

Do not use
• if imprinted seal under cap is broken or missing
• for teething
• in children under 2 years of age

When using this product

When using this product: avoid contact with eyes

Keep out of reach of children

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


• do not exceed recommended dosage

adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. 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 the product

children under 2 years of age: do not use

Other information

Other information
store at 20°-25° C (68°- 77° F)

Inactive ingredient

flavor, polyethylene glycol, sodium saccharin

Questions or comments?


M-F: 8:00 a.m. to 4:30 p.m. ET

Principal Display Panel

1oz Watermelon Gel Carton image

NDC 0283-0293-31


Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic


Manufactured for:

Beutlich Pharmaceuticals LLC

Bunnell, FL 32110

Made in the USA

1 oz.

benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0293
Route of AdministrationORAL, DENTAL, PERIODONTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
Colorwhite (colorless) Score    
FlavorWATERMELONImprint Code
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-0293-3128.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1993
2NDC:0283-0293-431 g in 1 PACKET; Type 0: Not a Combination Product01/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/15/1993
Labeler - Beutlich Pharmaceuticals, LLC (005209325)
NameAddressID/FEIBusiness Operations
Dental Technologies Inc.148312838manufacture(0283-0293)
NameAddressID/FEIBusiness Operations
Speciality Pharma Manufacturing013957125manufacture(0283-0293)

Revised: 12/2019
Document Id: a1b4cb09-683e-48ad-9f6e-7e64873743de
Set id: c113773b-dfb0-4797-ae0e-ecc06bfffd68
Version: 11
Effective Time: 20191224
Beutlich Pharmaceuticals, LLC