Anesgerm

Manufacturer: Caribe Natural, Inc | World Perfumes, Inc
Effective date: 2015-05-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:42:31

Label at a glance#

ProductAnesgerm

Active ingredientBENZOCAINE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Benzocaine 20% .................................... Pain Reliever

OTC - PURPOSE SECTION

Uses

for the temporary relief of pain due to:

toothache
minor irritation or injury of the mouth and gums
infection cause by dentures or orthodontic appliances
sore gums due to teething in infants and children 4 months of age and older

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

children under 12 years of age should be supervised in the use of this product. Adults and children 12 years of age and older:

apply to the affected area up to 4 times a day or as directed by a dentist or doctor

Children under 2 years of age:

consult a dentist or doctor

Teething Infants 4 months of age and over:

apply to the affected area up to 4 times daily or as directed by a dentist or doctor

Infants under 4 months of age:

consult a dentist or doctor

INDICATIONS & USAGE SECTION

GERMA

Anesterm

Maximum Strength Oral Pain Reliever

20% Benzocaine PLUS Oil of Cloves

Fast Pain Relief

Easy To Apply

Toothache
Sore Gums
Teething
Denture Irritation
Braces Irritation

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

Do not use

for more than 7 days unless directed by a dentist or doctor
if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days
infection, pain, or redness persists or worsens
swelling, rash or fever develops
fever & nasal congestion are present in teething infants 4 months of age and over

These symptoms may be a sign of infection or a serious condition.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

polyethylene glycol-75, polyethylene glycol-8, glycerin, propyl paraben, methyl paraben, sodium saccharin, clove oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1649341	ANESGERM 20 % Oral Gel	PSN	2
238910	benzocaine 20 % Oral Gel	PSN	2
1649341	benzocaine 0.2 MG/MG Oral Gel [Anesgerm]	SBD	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	2
1649341	Anesgerm 20 % Dental Gel	SY	2
1649341	Anesgerm 20 % Oral Gel	SY	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59561-001-01	2020-01-31	C162847	48780-1	9d75b9d1-209a-f424-e053-dadaa90a57ce	2bfa47d4-d772-481d-bee8-e0b1e80954a2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59561-001-01	Anesgerm	0.5 g in 1 PACKAGE	GEL	0.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59561-001	ANESGERM (BENZOCAINE) GEL [CARIBE NATURAL, INC]	2	Legacy NDC, 1 package rows	20150508_2bfa47d4-d772-481d-bee8-e0b1e80954a2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	2
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
CLOVE OIL	INACTIVE INGREDIENT	578389D6D0	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Anesgerm
Benzocaine
ALCOHOL
CLOVE OIL
GLYCERIN
METHYLPARABEN
POLYETHYLENE GLYCOL 1000
PROPYLENE GLYCOL
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59561-001	59561-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
ALCOHOL	3K9958V90M	IACT
CLOVE OIL	578389D6D0	IACT
GLYCERIN	PDC6A3C0OX	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL 1000	U076Q6Q621	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT

Source Document#

Source XML

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 · 340 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CLOVE OIL	CLOVE OIL	578389D6D0	SUSPENSION / ORAL	0.1 mg/5ml		Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000	POLYETHYLENE GLYCOL 1000	U076Q6Q621	GEL / TRANSDERMAL	0.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		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

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
1e87f799-696a-49d2-a852-94b345f24951			2bfa47d4-d772-481d-bee8-e0b1e80954a2	2015-05-08	Warnings	Exact identifier spl id: 1e87f799-696a-49d2-a852-94b345f24951 spl set id: 2bfa47d4-d772-481d-bee8-e0b1e80954a2

Reported adverse events (FAERS/openFDA)#

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