ISOPROPYL RUBBING ALCOHOL- alcohol liquid 
Pure Syncore 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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78785-001 Isopropyl Rubbing Alcohol - ISOPROPYL ALCOHOL 70%

Active Ingredient(s)

Isopropyl Alcohol 70% 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

Water

Package Label - Principal Display Panel

473 mL NDC: 78785-001-12 PDF 473 mL946 mL NDC: 78785-001-13 PDF 946 mL

ISOPROPYL RUBBING ALCOHOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78785-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78785-002-12473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2020
2NDC:78785-002-13946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Pure Syncore LLC (086277419)
Registrant - SEATEX LLC (026647404)

Revised: 1/2023
Document Id: f1e9d36d-986f-085e-e053-2995a90a2937
Set id: bbf770df-7331-9f79-e053-2a95a90a3cc0
Version: 2
Effective Time: 20230110
 
Pure Syncore LLC