Baby Orajel Naturals by Church & Dwight Co., Inc. / Church & Dwight Canada Corp. Baby Orajel Naturals

Baby Orajel Naturals by

Drug Labeling and Warnings

Baby Orajel Naturals by is a Homeopathic medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Church & Dwight Canada Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF- calcarea phosphorica, coffea cruda, chamomilla tablet, orally disintegrating 
Church & Dwight Co., Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Baby Orajel Naturals

Active Ingredient

Calcarea phosphorica, 3xHPUS
Coffea Cruda, 3xHPUS
Chamomilla, 3XHPUS

Purpose

Supports dentition
Wakefulness and diuresis
Irritability

Use

helps soothe swollen gums due to teething in infants and children 4 months of age and older

Warnings

Stop use and ask a doctor if

• pregnant or nursing
• symptoms persist for more than 7 days, if irritation persists, or if inflammation, fever or infection develops
  

Keep out of reach of children.

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

Directions

• dissolve 2 to 3 tables under the tongue or in a teaspoon of water, 4 times per day
• if the child is restless or wakeful, give 2 tablets every hour for 6 doses or as recommended by a licensed health care practitioner
  

Other information

• do not use if seal is cut or torn prior to opening
  

Inactive Ingredients

lactose spray dried, NF, microcrystalline cellulose, NF, stearic acid powder, NF

Questions or comments?

call us at 1-800-952-5080 M-F 9zm-5pm ET or visit our website at www.orajelnaturals.com

Carton Image

Number 1 TEETHING BRAND

used by Pediatricians

NDC-10237-903-12

Baby

Orajel

Naturals

for Teething Pain Relief

teething tablets

HELPS RELIEVE TEETHING DISCOMFORT

QUICK DISSOLVE Benzocaine-Free

TABLETS Dye-Free

Alcohol-Free

HOMEOPATHIC

NET WT 125 TABLETS

ORAL PAIN RELIEVER FOR TEETHING

Carton Image

BABY ORAJEL NATURALS  FOR TEETHING PAIN RELIEF
calcarea phosphorica, coffea cruda, chamomilla tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-903
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	3 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-903-00	1 in 1 CARTON	01/18/2016	09/24/2018
1		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 10237-903-12	1 in 1 CARTON	01/18/2016	09/24/2018
2		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/15/2011	09/24/2018

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp.		253933600	manufacture(10237-903)

Revised: 12/2019

Document Id: 9b02cc5b-b574-2f71-e053-2995a90a709f

34390-5

Set id: 905050bf-9f6c-4e05-959d-c1fd0d668acd

Version: 10

Effective Time: 20191231