CLEAN HAND SANITIZER TOPICAL GEL

CLEAN HAND SANITIZER by

Drug Labeling and Warnings

CLEAN HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Health Plus Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEAN HAND SANITIZER- alcohol gel 
Health Plus Inc.

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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CLEAN HAND SANITIZER TOPICAL GEL

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

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

Do not use

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

Inactive ingredients

Aloe, Aminomethyl propanol, Carbomer, Glycerin, Propanediol, Propylene Glycol, Vitamin E Acetate, Deionized Water.

Questions?

1-800-822-6225

Package Label-Principal Display Panel

2 Floz (59 mL)- NDC: 57348-898-20

Package Label- Principal Display Panel

4 Fl oz (118 mL)- NDC: 57348-898-40

CLEAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57348-898
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE (UNII: V5VD430YW9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57348-898-20	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2020	08/15/2022
2	NDC: 57348-898-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2020	08/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/24/2020	08/15/2022

Labeler - Health Plus Inc. (131279275)

Registrant - Health Plus Inc. (131279275)

Establishment
Name	Address	ID/FEI	Business Operations
Health Plus Inc.		131279275	manufacture(57348-898)

Revised: 8/2022

Document Id: a5c085ae-84c8-4d29-98aa-c2f72dbcead5

34390-5

Set id: ab660214-9da2-49a8-e053-2a95a90a7ea1

Version: 2

Effective Time: 20220812