Cut Care Insect Bite Antiseptic And Pain Relieving Wipe
FDA Label NDC 53439-120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zeus Medical Holdings Llc for the product Cut Care Insect Bite Antiseptic And Pain Relieving Wipe (NDC 53439-120). 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 ingredients, purpose, uses, warnings, do not use, stop use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzocaine, 6% w/v

Isopropyl Alcohol, 70% w/v

Purpose

Topical Analgesic

Antiseptic

Uses

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings

For external use only. Flammable, keep away from fire or flame.

Do Not Use

  • With electrocautery procedures.
  • In eyes

Stop Use

  • If irritation and redness develop.
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center right away

Directions

  • Adults and children 2 years of age and older, apply to affected area 3-4 times daily.
  • Children under 2 years; consult a physician.

Other Information

Avoid excessive heat. Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)

Inactive Ingredient:

purified water

Principal Display Panel

NDC 53439-120-10
Cut Care
Insect Bite Antiseptic & Pain Relieving Wipes
First aid antiseptic
Topical Analgesic
Contents: 100 Pre-Moistened Wipes

Ndc 53439-120-10cut Careinsect Bite Antiseptic & Pain Relieving Wipesfirst Aid Antiseptictopical Analgesiccontents: 100 Pre-moistened Wipes (Cut Care Insect Bite Antiseptic And Pain Relieving 01)

Ndc 53439-120-10cut Careinsect Bite Antiseptic & Pain Relieving Wipesfirst Aid Antiseptictopical Analgesiccontents: 100 Pre-moistened Wipes (Cut Care Insect Bite Antiseptic And Pain Relieving 01)

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