ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION- alcohol solution 
Sarkli-Repechage, Ltd.

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

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.

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

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

Stop 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.

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, purfied water USP

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


59 mL, NDC 64521-5678-2

59 mL label

236 mL, NDC 64521-5678-8 236 mL label

473 mL, NDC 64521-5678-1

473 mL label

ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64521-5678
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64521-5678-4118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
2NDC:64521-5678-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
3NDC:64521-5678-8236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/14/2020
4NDC:64521-5678-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2020
Labeler - Sarkli-Repechage, Ltd. (012583931)
Registrant - Sarkli-Repechage, Ltd. (012583931)
Establishment
NameAddressID/FEIBusiness Operations
Sarkli-Repechage, Ltd.012583931manufacture(64521-5678)

Revised: 4/2020
Document Id: a33fd467-2fbd-7eee-e053-2995a90ae098
Set id: a19c0b93-ae48-7b62-e053-2a95a90a701c
Version: 4
Effective Time: 20200414
 
Sarkli-Repechage, Ltd.