My Fair Baby oral gel

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2020-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:39

Label at a glance#

ProductMy Fair Baby oral gel Instant Pain Relief
Active ingredientBENZOCAINE
Label structure12 sections

Indications and uses

for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

Dosage and administration

■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 7.5%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

Warnings

WARNINGS SECTION

Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Do not use

OTC - DO NOT USE SECTION

■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider 

When using this product

OTC - WHEN USING SECTION

■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician

Stop use and ask a physician if

OTC - STOP USE SECTION

sore mouth symptoms do not get better in 7 days ■ irritation, pain or redness does not go away ■ swelling, rash or fever develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider

Other information

SPL UNCLASSIFIED SECTION

do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198496benzocaine 7.5 % Oral GelPSN1
198496benzocaine 0.075 MG/MG Oral GelSCD1
198496benzocaine 7.5 % Oral GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-180-022022-01-28C16284748780-1d6a99b39-e77f-a426-e053-dadaa90af4c2oral gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-180-01My Fair Baby oral gelInstant Pain Relief14 g in 1 TUBEGEL141
47046-180-02My Fair Baby oral gelInstant Pain Relief1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-180MY FAIR BABY ORAL GEL INSTANT PAIN RELIEF (BENZOCAINE) GEL [ANICARE PHARMACEUTICALS PVT. LTD.]1Legacy NDC, 2 package rows20201221_b6e209cf-2a60-e7e3-e053-2a95a90a64df.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-18047046-180-01, 47046-180-02

Ingredients#

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

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

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6e209cb-9f9c-4cb6-e053-2995a90a947ab6e209cf-2a60-e7e3-e053-2a95a90a64df2020-12-20WarningsExact identifier
spl id: b6e209cb-9f9c-4cb6-e053-2995a90a947a
spl set id: b6e209cf-2a60-e7e3-e053-2a95a90a64df

Reported adverse events (FAERS/openFDA)#

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