Baby Orajel Naturals Twin Pack

Manufacturer
Church & Dwight Co., Inc.
Effective date
2016-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:21:38

Label at a glance#

ProductBaby Orajel Naturals Twin Pack
Active ingredientTRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, PASSIFLORA INCARNATA FLOWER, ARABICA COFFEE BEAN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Daytime:

Calcarea phosporica, 12x HPUS

Chamomilla, 6x HPUS

Coffea cruda, 6x HPUS

Nightime:

Calcarea phosporica, 12x HPUS

Chamomilla, 6x HPUS

Coffea cruda, 6s HPUS

Passiflora incarnata (Passion Flower), 6x HPUS

OTC - PURPOSE SECTION

Supports dentition

Irratability

Restlessness

INDICATIONS & USAGE SECTION

Uses temporarily relieves the symptoms for simple restlessness and wakeful irritability due to cutting teeth, for children under 4 months of age, consult with your physician or healthcare provider

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 7 days or if irritatino persists; inflammation, fever or infection develops

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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 Orajel Naturals and spread over the gums

apply to the affected area up to 6 times daily or as directed by a physician or healthcare provide

for infants under 4 months of age, ask a physician or healthcare provider

Other Information

Do not use if tube tip is cut prior to opening

INACTIVE INGREDIENT SECTION

Daytime:

glycerin, hydroxyethylcellulose, potassium sorbate, sodium benzoate, sorbic acid, water

Nighttime:

flavor, glycerin, hydroxyethylcellulose, potassium sorbate, sodium benzoate, sorbic acid, water

OTC - QUESTIONS SECTION

Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 or visit our website at www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 Teething Brand

recommended by Pediatricians

Marca numero 1 recomendada

por Pediatras para la denticion

Baby

ORAJEL™

Naturals

for Teething Pain Relief

Para el alivio del dolor de la denticion

2 gels

Homeopathic Homeopaticas

Daytime & Nighttime

Twin Pack

Paraben-Free Benzocaine-Free Belladonna-Free Dye-Free

Sin parabeno Sin benzocaina Sin Belladona Sin tintes

HELPS RELIEVE TEETHING DISCOMFORT Ayuda A Aliviar El Malestar De La Denticion

2 TUBES NET WT 0.18 OZ (5.1g) EACH

Horizontal Pack 00005

BOJFC-00005-03HBOJFC-00005-03H

Vertical 00007

_BOJFC-00007-03V_BOJFC-00007-03V

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-75710237-757-18, 10237-757-19

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
40f4cc70-674b-44ef-e054-00144ff88e8840f4cc70-674a-44ef-e054-00144ff88e882016-11-10WarningsExact identifier
spl id: 40f4cc70-674b-44ef-e054-00144ff88e88
spl set id: 40f4cc70-674a-44ef-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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