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MAKESENSE Pain Relief

Dosage form: gel
Ingredients: BENZOCAINE 20g in 100g
Labeler: Cherry Hill Sales Co
NDC Code: 69020-207

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 20%

Purpose

Oral Pain Reliever

Uses

for the temporary relief of pain associated with:

■ toothache ■ canker sores ■ cold sores ■ fever blisters ■ minor dental procedures

Warnings

Allergy alert: do not use this product if your child 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 aska 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

Adults and children 2 years of age and older:■ cut open tip of tube ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ children under 12 years of age should be supervised using this product ■ 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

MAKESENSE  PAIN RELIEF
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-207
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
MINERAL OIL 
CERESIN 
PETROLATUM 
PROPANEDIOL 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:69020-207-1414 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)
Establishment
NameAddressID/FEIOperations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture(69020-207)

Revised: 07/2014
 
Cherry Hill Sales Co

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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