75% ALCOHOL- alcohol liquid 
Shandong Retouch Wash And Sterilize Technology Co.,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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75% Alcohol

Active Ingredient(s)

Alcohol 75% v/v. Purpose: First Aid Antiseptic

Purpose

First Aid Antiseptic

Use

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

For external use only. Flammable.

Keep away from heat, flame, spark, electrical.

Do not use

if allergy to alcohol

When using this product

keep out of eyes, ears, and mouth.

do not apply over large areas of the body.

do not use longer than 1 week unless directed by a doctor.

Stop use and ask a doctor if condition persists or gets worse.

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

Directions

Clean the affected area

Wash with this product on the area for 1-3 minutes

Other information

Store in a cool, dry place (below 86F). Keep sealed.

Supervises children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

purified water

Package Label - Principal Display Panel

500 mL NDC:75532-002-01

PDP

75532-002-01 1000ml

PDP

75532-002-03 4000ml

PDP

75% ALCOHOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75532-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75532-002-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
2NDC:75532-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
3NDC:75532-002-034000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/21/2020
Labeler - Shandong Retouch Wash And Sterilize Technology Co.,ltd. (529300365)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Retouch Wash And Sterilize Technology Co.,ltd.529300365manufacture(75532-002)

Revised: 2/2023
Document Id: f4638d67-9c7e-0f74-e053-2a95a90acae3
Set id: a3da4577-0a2d-6b15-e053-2995a90a34f2
Version: 4
Effective Time: 20230210
 
Shandong Retouch Wash And Sterilize Technology Co.,ltd.