MAKESENSE 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.

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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

image description

MAKESENSE  PAIN RELIEF
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 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:69020-207-1414 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/FEIBusiness Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture(69020-207)

Revised: 7/2014
Document Id: dbb2fffb-9c0c-4df5-ac7e-b15a9f83e28a
Set id: 4d553377-efec-4b6d-822c-46c301894d18
Version: 1
Effective Time: 20140730
 
Cherry Hill Sales Co