70% ISOPROPYL ALCOHOL- 70% isopropyl alcohol liquid 
Streamline Polymers 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.

----------

70% Isopropyl Alcohol Antiseptic

This is a first aid antiseptic. The product is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients.

  1. Isopropyl Alcohol (70%, v/v) in an aqueous solution.
  2. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Use(s) helps prevent the risk of infection in: minor cuts, scrapes, burns

Warnings

For external use only. Flammable. Keep away from fire or flame, heat, spark, electrical

When using this product keep out of eyes, do not inhale, do not apply over large areas of the body, do not use longer than 1 week.

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

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

clean the affected area, apply a small amount of this product on the area 1 to 3 times daily, may be covered with a sterile bandage, if bandaged, let dry first

Other information

Inactive ingredients

purified water USP

16 oz NDC: 74793-0008-2

16 oz 70% IPA 946 mL NDC: 74793-0008-1946 ml NDC: 74793-0008-1

70% ISOPROPYL ALCOHOL 
70% isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74793-0008
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
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74793-0008-1946 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/2020
Labeler - Streamline Polymers LLC (117054225)
Registrant - Streamline Polymers LLC (117054225)
Establishment
NameAddressID/FEIBusiness Operations
Streamline Polymers LLC117054225manufacture(74793-0008)

Revised: 9/2020
Document Id: b0101259-d738-61fe-e053-2a95a90aad5d
Set id: af5febcd-b462-4574-e053-2995a90aabf7
Version: 2
Effective Time: 20200924
 
Streamline Polymers LLC