SANICLEAN ALCOHOL ANTISEPTIC 77% TOPICAL SOLUTION GEL, UNSCENTED (HP2464)- alcohol gel 
HPPE LLC

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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HP2454 77% Ethanol, Unscented
NDC: 58039-116

Active Ingredient(s)

Alcohol 77% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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.

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, methylcellulose, purified water USP

Package Label - Principal Display Panel

1000000 mL NDC: 58039-116-01

1000 L Label

SANICLEAN ALCOHOL ANTISEPTIC 77% TOPICAL SOLUTION GEL, UNSCENTED (HP2464) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58039-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58039-116-011000000 mL in 1 CONTAINER; Type 0: Not a Combination Product04/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/23/2020
Labeler - HPPE LLC (078769356)
Establishment
NameAddressID/FEIBusiness Operations
HPPE LLC078769356manufacture(58039-116)

Revised: 4/2020
Document Id: a9cb133b-716b-cb47-e053-2995a90ac663
Set id: a9caf439-3bb9-645b-e053-2a95a90ac8e7
Version: 1
Effective Time: 20200423
 
HPPE LLC