Baby Orajel Teething Medicine

Generic Name: benzocaine

Dosage Form: topical liquid
DRUG FACTS

Active ingredient      Purpose

Benzocaine 7.5%                  Oral pain reliever

Use for the temporary relief of sore gums due to teething in infants and children 4 months of age and older

Allergy Alert

do not use this product if our baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics


Do not use

more than directed, for more than 7 days unless told to do so by a dentist or doctor


When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection.   If these symptoms do not go away, advise your dentist or doctor.


Stop use and ask a dentist of doctor if sore mouth symptoms do not get better in 7 days, irritation, pain or redness does not go away, swelling, rash or fever 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

wash hands,

remove imprinted bottle safety seal from bottle

use your fingertip or cotton applicator to apply 2-4 drops of BABY ORAJEL,

apply to the affected area up to four times daily or as told to do so by a dentist or doctor,

for infants under 4 months of age, ask a dentist or doctor

Other information

Do not use if imprinted bottle safety seal is broken or missing


Inactive ingredients  ammonium glycyrrhizate, chamomilla recutita (mtricaria) flower extract, flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, red 40, sodium saccharin, sorbic acid, sorbitol

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

Baby Orajel Liquid Teething Medicine

Carton image

Baby Orajel Teething Medicine  benzocaine  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10237-711 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE .075 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCYRRHIZIN, AMMONIATED   MATRICARIA RECUTITA   GLYCERIN   METHYLPARABEN   POLYETHYLENE GLYCOL   PROPYLPARABEN   WATER   FD&C RED NO. 40   SACCHARIN SODIUM   SORBIC ACID   SORBITOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10237-711-45 1 BOTTLE In 1 CARTON contains a BOTTLE 1 13.3 mL In 1 BOTTLE This package is contained within the CARTON (10237-711-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/29/2010

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

Establishment
Name	Address	ID/FEI	Operations
Accupac		071609663	manufacture

Revised: 07/2010Church & Dwight Co., Inc.

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