DELISTED - Hand Sanitizer (80083-002)

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pristine LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Pristine 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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DELISTED - Hand Sanitizer (80083-002)

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• 

OTC When Using

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.

OTC Keep out of reach of children

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 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, bubblegum fragrance

Package Label - Principal Display Panel

100 mL NDC: 80083

Distributed by Pristine LLC 2415 West Alabama Street, Ste 200, Houston, TX 77098. Info@cobalt-clean.com NDC Labeler Code 80083

'

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80083-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BITTER ORANGE OIL (UNII: 9TLV70SV6I)	0.0624 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80083-002-01	100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/11/2020
2	NDC: 80083-002-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	05/19/2022

Labeler - Pristine LLC (117619238)

Registrant - Pristine LLC (117619238)

Revised: 5/2021

Document Id: c2c64f7e-cd75-1469-e053-2a95a90a3687

34390-5

Set id: aefce1a1-b97a-7d92-e053-2a95a90af171

Version: 3

Effective Time: 20210520

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