BABY ORAJEL NATURALS TWIN PACK- orajel naturals 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.

----------

Orajel Naturals Drug Facts Twin Pack

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

Supports dentition

Irratability

Restlessness

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

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

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

Daytime:

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

Nighttime:

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

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

#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-00005-03H

Vertical 00007

_BOJFC-00007-03V

BABY ORAJEL NATURALS TWIN PACK 
orajel naturals gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-757
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 g
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER6 [hp_X]  in 1 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-757-181 in 1 CARTON01/01/201509/27/2019
15.1 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10237-757-191 in 1 CARTON01/01/201509/27/2019
25.1 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/201509/27/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-757)

Revised: 12/2019
 
Church & Dwight Co., Inc.