Baby Orajel Naturals by Church & Dwight Co., Inc. 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF- calcarea phosphorica, chamomilla, coffea cruda gel 
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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Orajel Naturals

Active ingredients

Calcarea phosporica, 12x HPUS

Chamomilla, 6x HPUS

Coffea cruda, 6s HPUS

Purpose

Supports dentition

Irritability

Wakefullness and diuresis

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

Warnings

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

Keep out to reach of children

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

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

Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm or visit our webiste at www.orajelnaturals.com

#1 TEETHING BRAND

recommended by Pediatricians

Baby

Orajel

Naturals

for Teething Pain Relief

gel

BABY ORAJEL NATURALS  FOR TEETHING PAIN RELIEF
calcarea phosphorica, chamomilla, coffea cruda gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-742
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X]  in 1 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-742-33	1 in 1 CARTON	12/01/2012	09/09/2019
1		9.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-742-34	1 in 1 CARTON	12/01/2012	09/09/2019
2		9.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2012	09/09/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-742)

Revised: 12/2019

Document Id: 9b02d09b-a74c-666f-e053-2a95a90aa89e

34390-5

Set id: a7928b28-1f9b-4bcc-962a-bb01cb04d7d1

Version: 7

Effective Time: 20191231