Kroger
FDA Label NDC 30142-354

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger for the product Kroger (NDC 30142-354). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20.0% ..................................Oral pain reliever

Menthol 0.25% .......................................Oral pain reliever

Benzalkonium Chloride 0.1% ....................Antiseptic

Uses

for the temporary relief of pain due to toothaches

to help protect against infection of minor oral irritation

Warnings

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

When using this product

  • do not use more than directed
  • for more than 7 days unless told to do so by a dentist or doctor

    • Stop use and ask a doctor if

    • swelling rash or fever developes
    • irritation, pain or redness persists or worsens
    • symptoms do not improve in 7 days
    • allergic reaction occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • cut open tip of tubne on score mark
  • adults and children 2 years of age and older; apply a small amount of product to the cavity and arround the gum surrounding the teeth
  • use up to 4 times daily or as directed by a dentist or doctor. 
  • Children under 12 years of age should be supervised in the use of this product.

    • Children under 2 years of age: ask a dentist or doctor.

Other Information

  • do not use if tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • do not use continuously
  • this formula will stay in place for an extended duration of relief
  • avoid using toothpaste or drinking softdrinks or fruit juices for at least one hour after applying

Inactive Ingredients

Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin

Dosage & Administration

Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age should be supervised in the use of this product.
Children under 2 years of age: ask a dentist or doctor.

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