Alcohol Antiseptic 80 Percent Topical: Package Insert and Label Information

ALCOHOL ANTISEPTIC 80 PERCENT TOPICAL- alcohol solution
Chattem, 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.

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer Non-sterile Solution

Drug Facts

Active i ngredient

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.

■ Healthcare personnel hand rub to help reduce bacteria that potentially can cause disease.

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 right away.

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

PRINCIPAL DISPLAY PANEL

Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-Sterile Solution
4.2 FL OZ (124 mL)

Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer
Non-Sterile Solution 
4.2 FL OZ (124 mL)
(click image for full-size original)
ALCOHOL ANTISEPTIC 80 PERCENT TOPICAL
alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-4700
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
GLYCERIN
HYDROGEN PEROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-4700-0 124 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333A 04/01/2020
Labeler — Chattem, Inc. (003336013)

Revised: 04/2020 Chattem, Inc.

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