MAKESENSE JUNIOR PAIN RELIEF- benzocaine gel 
Cherry Hill Sales Co

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredient

Benzocaine 7.5%

Purpose

Oral Pain Reliever

Uses

for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

Warnings

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

Do not use

■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider 

When using this product

■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician

Stop use and ask a dentist or 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 immediately.

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 MakeSense Junior Teething Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ for infants under 2 years of age, ask a doctor or health care provider

Other information

■ store at 59 to 77F (15-25C) ■ do not use if tube tip is cut prior to opening

Inactive ingredients

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

Package Label

image description

MAKESENSE  JUNIOR PAIN RELIEF
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-206
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
CERESIN (UNII: Q1LS2UJO3A)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69020-206-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/15/2014
Labeler - Cherry Hill Sales Co (145959768)

Revised: 7/2014
Document Id: 90caa440-ee24-40b9-9ea6-6e4003469c8c
Set id: 1c1d1577-8a51-436c-9af2-986c36389ddf
Version: 1
Effective Time: 20140730
 
Cherry Hill Sales Co