SANICLEAN ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION GEL, CITRUS FLORAL SCENTED (HP2511)- isopropyl 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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Saniclean HP Isopropyl Alcohol Antiseptic 75% Topical Solution Gel, Citrus Floral Scented (HP2511)

Active Ingredient(s)

Isopropyl Alcohol 75% 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

citrus floral fragrance, glycerin, PEG-6 AMP-acrylates/vinyl isodecanoate crosspolymer, purified water USP

Package Label - Principal Display Panel

1000000 mL NDC: 58039-213-01

1000 L Label

SANICLEAN ISOPROPYL ALCOHOL ANTISEPTIC 75% TOPICAL SOLUTION GEL, CITRUS FLORAL SCENTED (HP2511) 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58039-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58039-213-011000000 mL in 1 CONTAINER; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/30/2020
Labeler - HPPE LLC (078769356)
Establishment
NameAddressID/FEIBusiness Operations
HPPE LLC078769356manufacture(58039-213)

Revised: 8/2020
Document Id: acc9163e-a7a6-df57-e053-2a95a90a586e
Set id: b088b0dd-3fbc-8736-e053-2995a90a21d8
Version: 1
Effective Time: 20200813
 
HPPE LLC