Isopropyl Alcohol by INEOS COMPOSITES US, LLC / INEOS COMPOSITES, US LLC

Isopropyl Alcohol by

Drug Labeling and Warnings

Isopropyl Alcohol by is a Otc medication manufactured, distributed, or labeled by INEOS COMPOSITES US, LLC, INEOS COMPOSITES, US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ISOPROPYL ALCOHOL- isopropyl alcohol gel 
INEOS COMPOSITES US, 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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Active ingredients

Isopropyl Alcohol 75% v/v

Purpose

Antiseptic, Hand Sanitizer

Uses

Hand sanitizer to help reduce bacteria that can potentially 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

on children less than 2 months of age
on open skin wounds

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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

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

Other information

Store between 59-86°F

Inactive ingredients

Water (Aqua), Methylacrylic Acid-Ethyl Acrylate Copolymer, Glycerin, Aminomethylpropanol

50mL NDC: 75284-0200-1 250ml NDC: 75284-0200-8

500mL NDC: 75284-0200-9

ISOPROPYL ALCOHOL 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75284-0200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	3.82 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20.42 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.09 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.67 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75284-0200-1	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2021	10/20/2021
2	NDC: 75284-0200-8	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2021	10/20/2021
3	NDC: 75284-0200-9	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2021	10/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2021	10/20/2021

Labeler - INEOS COMPOSITES US, LLC (117196678)

Registrant - INEOS COMPOSITES, US LLC (116877629)

Establishment
Name	Address	ID/FEI	Business Operations
INEOS COMPOSITES US, LLC		117196678	manufacture(75284-0200) , label(75284-0200) , pack(75284-0200)

Revised: 10/2021

Document Id: cece0dca-6d02-c1e7-e053-2a95a90a0095

34390-5

Set id: badaf346-7ef4-8b02-e053-2a95a90a0ea3

Version: 5

Effective Time: 20211020