MAKESENSE PAIN RELIEF (BENZOCAINE) GEL [CHERRY HILL SALES CO]

MAKESENSE PAIN RELIEF (BENZOCAINE) GEL [CHERRY HILL SALES CO]
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NDC 69020-207-14
Set ID 4d553377-efec-4b6d-822c-46c301894d18
Category HUMAN OTC DRUG LABEL
Packager Cherry Hill Sales Co
Generic Name
Product Class
Product Number
Application Number PART356
  • 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

  • INGREDIENTS AND APPEARANCE
    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)

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