Gumsol

Manufacturer: Kramer Novis
Effective date: 2018-11-22
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:57:33

Label at a glance#

ProductGumsol

Active ingredientBENZOCAINE, ZINC CHLORIDE

Label structure10 sections

Dosage and administration

Adults and children 12 years of age and older Dry affected area with absorbent cotton. Apply 4 times daily with cotton applicator. Children under 12 years of age Should be supervised in the usage of this product. Children under 2 years of age Do not use.

Storage and handling

• Phenylketonurics: Contains phenylalanine 2.5mg/mL. • Store at controlled room temperature: 15°C-30°C (59°F-86°F) • Tamper Evident:Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.

Contacts and useful links#

PhoneLabel contact787-767-2072

Websitewww.kramernovis.com

www.kramernovis.com

Label contents#

Full prescribing information#

Active ingredients (in 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine (5%)

Zinc Chloride (0.1%)

Purposes

OTC - PURPOSE SECTION

Anesthetic

Astringent

Use

INDICATIONS & USAGE SECTION

Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries of the mouth and gums caused by dentures or orthodontic appliances.

Warnings

WARNINGS SECTION

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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetic. If skin reaction occurs, stop use and seek medical help right away.

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

Do not use (unless directed by a doctor): • more than directed • for more than 7 days • in children under 2 years of age • for teething.

Stop use and see a doctor promptly if: • sore mouth symptoms do not improve in 7 days

• irritation, pain or redness persist or worsen

• swelling, rash or fever develops.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


Adults and children 12 years of age and older	Dry affected area with absorbent cotton. Apply 4 times daily with cotton applicator.
Children under 12 years of age	Should be supervised in the usage of this product.
Children under 2 years of age	Do not use.

Other information:

STORAGE AND HANDLING SECTION

• Phenylketonurics: Contains phenylalanine 2.5mg/mL.

• Store at controlled room temperature: 15°C-30°C (59°F-86°F)

• Tamper Evident:Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified).

Questions or comments?

OTC - QUESTIONS SECTION

Kramer Novis San Juan, PR 00917. Monday to Friday

(8am-4pm). 787-767-2072 www.kramernovis.com

SPL UNCLASSIFIED SECTION

Oral Topical Solution

Alcohol Free

Manufactured in the USA for

Kramer Novis, San Juan, PR 00917

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gumsnew

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
485560	benzocaine 5 % / zinc chloride 0.1 % Mucous Membrane Topical Solution	PSN	2
485560	benzocaine 50 MG/ML / zinc chloride 1 MG/ML Mucous Membrane Topical Solution	SCD	2
485560	benzocaine 5 % / zinc chloride 0.1 % Mucous Membrane Topical Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-713-01	2023-01-30	C162847	48780-1	f386c64a-3ec2-0266-e053-dadaa90a7c1a	GUMSOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-713-01	Gumsol	30 mL in 1 BOTTLE	SOLUTION	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-713	GUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]	2	Legacy NDC, 1 package rows	20181211_3ef75f3c-cc00-4b39-9249-161da76bb9a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-713-01	ML - Milliliter	52083-713	f1176c0e-c5ff-4c4b-a337-ffc7dd17be68	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
ZINC CHLORIDE	ACTIVE INGREDIENT	86Q357L16B	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	1
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Gumsol
Benzocaine, Zinc Chloride
BENZOCAINE
ZINC CHLORIDE
ZINC CATION
ASPARTAME
CETYLPYRIDINIUM CHLORIDE
GLYCERIN
MENTHOL, UNSPECIFIED FORM
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52083-713	52083-713-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
ZINC CHLORIDE	86Q357L16B	ACTIM
ASPARTAME	Z0H242BBR1	IACT
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 351 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDE	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	FILM, EXTENDED RELEASE / BUCCAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SOLUTION / ORAL	233 mg		Exact identifier — unii candidate 19 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
371d4ba3-420a-412c-ad8a-d88aa68c0d5b			3ef75f3c-cc00-4b39-9249-161da76bb9a7	2018-11-22	Warnings	Exact identifier spl id: 371d4ba3-420a-412c-ad8a-d88aa68c0d5b spl set id: 3ef75f3c-cc00-4b39-9249-161da76bb9a7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.