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Home > Drugs > Mouth and throat products > Orajel dry mouth moisturizing > Baby Orajel Teething Medicine Prescribing Information
Mouth and throat products
https://themeditary.com/pro/baby-orajel-teething-medicine-prescribing-information-15040.html

Baby Orajel Teething Medicine Prescribing Information

Drug Detail:Orajel dry mouth moisturizing (Saliva substitutes [ sa-lye-va-sub-sti-tutes ])

Drug Class: Mouth and throat products

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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

Carton image

BABY ORAJEL TEETHING MEDICINE
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-711
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE.075 mL in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-711-451 in 1 CARTON
113.3 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac071609663manufacture

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