OLP Baby Teething

Manufacturer
Ohio Lab Pharma
Effective date
2020-04-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:44

Label at a glance#

ProductOLP Baby Teething
Active ingredientBENZOCAINE
Label structure11 sections

Indications and uses

temporarily relieves sore gums due to teething in infants and children 4 months of age and older 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” anesthetics Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor. When using this product fever and nasal congestion are not sym...

Dosage and administration

wash hands cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of baby teething gel apply to affected area up to four times daily or as directed by a dentist or doctor for infants under 4 months of age, ask a dentist or doctor

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves sore gums due to teething in infants and children 4 months of age and older

Warnings

WARNINGS SECTION

  • 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” anesthetics

  • Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor.
  • When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your dentist or doctor.
  • Stop use and ask a doctor if sore mouth symptoms do not get better in 7 days. swelling, rash or fever develops, irritation, pain or redness persists or worsens
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

OTC - PURPOSE SECTION

anaesthetic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 7.5%

Other information

OTHER SAFETY INFORMATION

store at 15 to 25 C(59-77F)

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash hands
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of baby teething gel
  • apply to affected area up to four times daily or as directed by a dentist or doctor

for infants under 4 months of age, ask a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow 5, FD&C Red 40, Flavor, Glycerin, Poropylene Glycols, Purified Water, Sorbic Acid, , carbomer, methyl paraben, propyl paraben

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 do not go away. advise your physician

stop using and ask a dentist or physician

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 contact a poison control center right away

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NET WEIGHT 0.33 oz (9.4g)

NDC#70648-999-01

olp baby teething gelolp baby teething gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198496benzocaine 7.5 % Oral GelPSN2
198496benzocaine 0.075 MG/MG Oral GelSCD2
198496benzocaine 7.5 % Oral GelSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70648-999-01OLP Baby Teething1 in 1 CARTONGEL12
70648-999-01OLP Baby Teething9.4 g in 1 TUBEGEL9.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70648-999OLP BABY TEETHING (BENZOCAINE) GEL [OHIO LAB PHARMA]2Legacy NDC, 2 package rows20200826_5fb4a35b-4567-020e-e053-2991aa0a8b29.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70648-99970648-999-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
7b9ba87e-0224-c428-e053-2a91aa0a12775fb4a35b-4567-020e-e053-2991aa0a8b292020-04-01WarningsExact identifier
spl id: 7b9ba87e-0224-c428-e053-2a91aa0a1277
spl set id: 5fb4a35b-4567-020e-e053-2991aa0a8b29

Reported adverse events (FAERS/openFDA)#

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