OTC Medication Information: Antiseptic

ANTISEPTIC- alcohol and lidocaine hydrochloride liquid
Total Resources International

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.

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.

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
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ANTISEPTIC
alcohol, lidocaine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55550-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alcohol (alcohol) alcohol 500 mg in 1 g
lidocaine hydrochloride (lidocaine) lidocaine hydrochloride anhydrous 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride
menthol
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55550-100-02 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 01/14/2020
Labeler — Total Resources International (790160535)

Revised: 01/2020 Total Resources International

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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