HDX Hand Sanitizer (16oz) NDC: 78253-0004-1

HDX Hand Sanitizer by

Drug Labeling and Warnings

HDX Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by JVL Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HDX HAND SANITIZER- alcohol gel 
JVL Laboratories, 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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HDX Hand Sanitizer (16oz) NDC: 78253-0004-1

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

To help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from source of heat or fire

Do not use

• in children less than 2 months of age
• on open skin wounds
• on broken or damaged skin

When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Stop use and ask a doctor if irritation or redness develops and lasts

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• for occasional and personal use
• rub thoroughly into hands for at least 30 seconds. allow to dry
• children under 6 years should be supervised when using this product

Other information

• store at temperature below 110 F (43 C)
• may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Aloe Barbadensis Leaf Juice, Isopropyl Myistate, Glycerin, Isopropyl Alcohol, Tocopheryl Acetate, Ethylene Brassylate

Questions or Comments? 1-866-695-3030

Package Label - Principal Display Panel

HDX Hand Sanitizer (gel) NDC: 78253-0004-1

HDX HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78253-0004
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
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78253-0004-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/14/2021	08/04/2021

Labeler - JVL Laboratories, Inc. (969604503)

Revised: 9/2022

Document Id: e94a3d17-5653-3e64-e053-2995a90aa402

34390-5

Set id: c250fc57-4b3e-9233-e053-2995a90a8e5a

Version: 3

Effective Time: 20220922