IDO Clean Gel Alpha Hand Sanitizer 500 mL

IDO Clean Gel Alpha Hand Sanitizer by

Drug Labeling and Warnings

IDO Clean Gel Alpha Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by IDO PHARM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IDO CLEAN GEL ALPHA HAND SANITIZER- alcohol gel 
IDO PHARM

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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IDO Clean Gel Alpha Hand Sanitizer 500 mL

Active Ingredient

Ethyl Alcohol 72%

Purpose

Antiseptic

Uses

• hand sanitizer to help reduce bacteria on the skin
• recommended for repeated use

Warnings

​ Flammable. Keep away from heat or flame.

For external use only: hands

When using this product

• keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water
• avoid contact with broken skin
• do not inhale or ingest

Stop use and ask a doctor if

• skin irritation or redness develops
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hand thoroughly with product and allow to dry without wiping
• children under 6 years of age, should be supervised when using this product
• not recommended for infants

Other information

• avoid freezing and excessive heat above 104°F (40°C)
• may discolor certain fabrics
• harmful to wood finishes and plastics

Inactive ingredients

Water, Carbomer, Triethanolamine, Glycerin, Tocopheryl Acetate

Package Label - Principal Display Panel

IDO Clean Gel Alpha

Hand Sanitizer

500 ml

Net Wt. 16.9 fl. oz

IDO CLEAN GEL ALPHA HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77039-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77039-073-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2020	12/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/30/2020	12/24/2021

Labeler - IDO PHARM (694853523)

Establishment
Name	Address	ID/FEI	Business Operations
IDO PHARM		694853523	manufacture(77039-073)

Revised: 12/2021

Document Id: d3e5f1c1-14c5-b8ef-e053-2a95a90a7dd6

34390-5

Set id: a749a087-8e3b-946a-e053-2995a90a1bf4

Version: 2

Effective Time: 20211224