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Drug Facts
Antiseptic
FDA Label NDC 61010-7200
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 61010-7200). 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
Active Ingredients
Ethyl alcohol 50.0%
Benzocaine 6.0%
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 Ingredients
benzalkonium chloride, menthol, purified water
Principal Display Panel – Pouch Label
NDC 61010-7200-0
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 – Pouch Label (Sti00 0000 01)
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