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Name:Antiseptic
Manufacturer:Safetec Of America, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ANTISEPTIC - alcohol and benzocaine liquid 
Safetec of America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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

ANTISEPTIC 
alcohol, benzocaine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-7200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alcohol (alcohol) alcohol 500 mg  in 1 g
benzocaine (benzocaine) benzocaine 60 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride  
menthol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61010-7200-0 0.8 g in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/12/2011

Labeler - Safetec of America, Inc. (874965262)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE

Revised: 05/2011 Safetec of America, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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