GOODSENSE ORAL PAIN RELIEF- benzocaine gel 
Geiss, Destin and Dunn, 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.

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GoodSense Oral Pain Relief Gel 0.5oz (191)

Active ingredient                                                   Purpose

Benzocaine 20%................................................. Oral pain reliever

Uses

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 use this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

Allergy Alert: do not use this product if your child has 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 doctor.

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

Questions or comments?

Call 1-888-645-8204 Monday - Friday 9AM-5PM (PST)

Distributed by:

Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-645-8204

Made in China

191

GOODSENSE ORAL PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-191
Route of AdministrationTOPICAL
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)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
MINT (UNII: FV98Z8GITP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-191-101 in 1 CARTON12/18/2018
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 finalpart333B05/09/2014
Labeler - Geiss, Destin and Dunn, Inc. (076059836)

Revised: 5/2022
Document Id: dfdced39-6938-4f2d-e053-2a95a90a6f2e
Set id: eb461b70-d10f-4e11-8374-e43713f3504d
Version: 9
Effective Time: 20220525
 
Geiss, Destin and Dunn, Inc.