ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION- alcohol solution

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution by

Drug Labeling and Warnings

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution by is a Otc medication manufactured, distributed, or labeled by Sarkli-Repechage, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient[s]
Alcohol 80% v/v

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.

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.

WARNINGS

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

DO NOT USE

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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.

INSTRUCTIONS FOR USE

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.

STORAGE AND HANDLING

Other information
Store between 15–30C (59–86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purfied water USP

QUESTIONS

Questions or comments?
Call Toll-Free 1-800-SKIN (1-800-248-7546) Monday-Friday 9am-5:30pm ET

Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution

118 mL, NDC: 64521-5678-4

59 mL, NDC: 64521-5678-2

236 mL, NDC: 64521-5678-8

473 mL, NDC: 64521-5678-1

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64521-5678
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64521-5678-4	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
2	NDC: 64521-5678-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
3	NDC: 64521-5678-8	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2020
4	NDC: 64521-5678-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

Labeler - Sarkli-Repechage, Ltd. (012583931)

Registrant - Sarkli-Repechage, Ltd. (012583931)

Establishment
Name	Address	ID/FEI	Business Operations
Sarkli-Repechage, Ltd.		012583931	manufacture(64521-5678)