SanitFresh Antiseptic Hand Sanitizer 8OZ

Dosage form: gel
Ingredients: ALCOHOL 72mL in 100mL
Labeler: Wormser Corporation
NDC code: 78512-001

Medically reviewed by Drugs.com. Last updated on May 26, 2023.

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:

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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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)

Alcohol 72% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer 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 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.

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

Inactive ingredients

Water, Carbomer, Aminomethyl Propanol,Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Ethyl Hexanediol, Phenoxyethanol

Package Label - Principal Display Panel

236 mL NDC: 78512-001-00

SANITFRESH ANTISEPTIC HAND SANITIZER 8OZ
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78512-001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	72 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN	0.01 mL in 100 mL
WATER	27.65597 mL in 100 mL
AMINOMETHYLPROPANOL	0.06303 mL in 100 mL
BUTYLENE GLYCOL	0.01 mL in 100 mL
ALOE VERA LEAF	0.0098 mL in 100 mL
ETHOHEXADIOL	0.00015 mL in 100 mL
PHENOXYETHANOL	0.00005 mL in 100 mL
ISOPROPYL MYRISTATE	0.001 mL in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0.25 mL in 100 mL

Packaging
#	Item Code	Package Description
1	NDC:78512-001-00	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/08/2020

Labeler - Wormser Corporation (150857043)

Registrant - Nu-World Corporation (628045858)

Establishment
Name	Address	ID/FEI	Operations
Nu-World Corporation		628045858	manufacture(78512-001)

Document Id: a75b743a-017e-613a-e053-2995a90a07d3

Set id: a75b79dd-fa16-73fe-e053-2a95a90abb49

Version: 1

Effective Time: 20200605

Wormser Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer