Baby Orajel Naturals for Teething Pain Relief

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- calceria carbonica, calceria phosphorica, chamomilla, coffea cruda, passiflora incarnata, terebinthina 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 for Teething Pain Relief

Calcarea carbonica, Calcarea phosphorica, Chamomilla, Coffea cruda, Passiflora incarnata (Passion Flower), Terebinthina

Calcarea carbonica - Delayed or slow teething

Calcarea phosphorica - Difficult teething, dentition

Chamomilla - Irritibility, crying and whining

Coffea cruda - Occassional sleeplessness, restlessness

Passiflora incarnata - Restlessness

Terebinthia - Irritability

Uses

Temporarily relieves the multiple symptoms of dentition, restlessness and wakeful irritability due to cutting teeth. For children under 2, consult your physician or healthcare provider.

WARNINGS

Stop use and ask a doctor if symptoms persist for more than 7 days, if irritation persists of 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 2-3 tablets (1 at a time) under baby's tongue or in a teaspoon of water prior to being given to baby. Can give 2-3 tablets every hour up to 4 times per day or as recommended by a licensed healthcare professional.

Other information

Do not use if seal is cut or torn prior to opening

Store in dry environment

Leave SorbiCap desiccant in bottle

Cellulose, lactose, magnesium stearate, mannitol, starch

Questions or comments. Call us at 800 952 5080 or visit www orajel com

#1 TEETHING BRAND

recommended by Pediatricians

La marca numero 1

para la denticion

mas recomendada

por pediatras

Fast Dissolving

Baby

Orajel

Naturals

for Teething Pain Relief

Para el alivio del dolor de las denticion

HOMEOPATHIC Homeopatico

MULTI-SYMPTOM TEETHING RELIEF

Multiples sintomas

  • Teething Discomfort Molestia de la denticion
  • Restlessness & Irritability Inquietud e irritabilidad
  • First Tooth Development Aparicion de los primeros dientes

ORAL PAIN RELIEVER FOR TEETHING

Analgesico Oral Para La Denticion

135 TABLETS

Tabletas

BOJFC-32371-06

BOJFC-32371-06

BABY ORAJEL NATURALS 
calceria carbonica, calceria phosphorica, chamomilla, coffea cruda, passiflora incarnata, terebinthina tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10237-908
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6   in 1 [hp_X]
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL7   in 1 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12   in 1 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6   in 1 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6   in 1 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12   in 1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE (UNII: J2B2A4N98G)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10237-908-121 in 1 CARTON01/18/201609/24/2018
1135 [hp_X] in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/18/201609/24/2018
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Canada Corp.253933600manufacture(10237-908)

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