Antiseptic
FDA Label NDC 55550-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Total Resources International for the product Antiseptic (NDC 55550-100). 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 other, active ingredients, purpose, uses, warnings, do not use, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Ethyl alcohol 50.0% v/v

Lidocaine HCI 2.0% w/w

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do Not Use

  • over large areas of the body
  • in eyes
  • over raw or blistered areas.

Otc - Stop Use

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

Directions

Adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age: Consult a doctor.

Inactive Ingredients

benzalkonium chloride, menthol, purified water

Principal Display Panel – Pouch Label

BE SMART

GET PREPARED

STING
RELIEF WIPE

1 PC

Pre-moistened Wipe

SINGLE USE

Made in USA • Mfd. for: TOTAL RESOURCES INTL. • Walnut, California 91789

00-BEE-90103 Rev.01 • NDC #55550-100-02

Figure (Tot07 0000 01)

Figure (Tot07 0000 01)

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