Pilot Alcohol Antiseptic 80% Topical Solution: Package Insert and Label Information

PILOT ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION- alcohol solution
Pilot Chemical Company

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 ingredient[s]

Alcohol 80% v/v

Purpose
Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings
For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

PILOT CHEMCICAL COMPANY
Water provided by Culligan of Fairfield
Alcohol Antiseptic 80% Topical Solution
HAND SANITIZER Non-Sterile Solution
8 oz (237 mL)
16 oz (473 mL)
1 gallon (3.78 L)
Distributed by Pilot Chemical Company
West Chester, OH 45069
1 (800)70-PILOT

Pilot PDP FDA COVID
(click image for full-size original)
PILOT ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION
ethanol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73602-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
HYDROGEN PEROXIDE
WATER
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73602-003-01 237 mL in 1 BOTTLE, SPRAY None
2 NDC:73602-003-02 473 mL in 1 BOTTLE, PUMP None
3 NDC:73602-003-03 3780 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/01/2020
Labeler — Pilot Chemical Company (008287823)
Establishment
Name Address ID/FEI Operations
Pilot Chemical Company 139641146 manufacture (73602-003)

Revised: 06/2020 Pilot Chemical Company

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