Antiseptic Liquid
FDA Label NDC 61010-5200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Antiseptic (NDC 61010-5200). 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.

Other

Antiseptic towelette

Drug Facts

Active Ingredients

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

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 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 a 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 Ingredient

Inactive ingredients benzalkonium chloride, menthol, purified water

Principal Display Panel – Mini Pouch Label

Safetec

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

EXP. LOT

Principal Display Panel – Mini Pouch Label (Sti02 0001 01)

Principal Display Panel – Mini Pouch Label (Sti02 0001 01)

Principal Display Panel – 150 Count Box

Safetec

NDC 61010-5200-4

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

Reorder No.
52004

Contents: 150 single-use, premoistened towelettes

Principal Display Panel – 150 Count Box (Sti02 0001 02)

Principal Display Panel – 150 Count Box (Sti02 0001 02)

Principal Display Panel – 2 Fl. Oz. Bottle

NDC 61010-5200-1

Safetec

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

2 fl. oz. (59.1 ml)

Reorder No.
52001
Package Not Child Resistant

Principal Display Panel – 2 Fl. Oz. Bottle (Sti02 0001 03)

Principal Display Panel – 2 Fl. Oz. Bottle (Sti02 0001 03)

Principal Display Panel – 25 Count Box Label

NDC 61010-5200-7

Safetec

Sting Relief

Insect Bite

Antiseptic and Pain Reliever

Contents: 25 single-use, premoistened towelettes

Principal Display Panel – 25 Count Box Label (Sti02 0001 04)

Principal Display Panel – 25 Count Box Label (Sti02 0001 04)

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