Hand Sanitizer by VITANE PHARMACEUTICALS, INC. / VITANE PHARMACEUTICALS INC

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by VITANE PHARMACEUTICALS, INC., VITANE PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- silky touch hand sanitizer liquid 
VITANE PHARMACEUTICALS, 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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Active Ingredient

Alcohol 70% v/v. Purpose: Antiseptic

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.

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

Deionized Water, Ceraphyl 31, Glycerin, Hydroxypropylcellulose, Fragrance (Perfume).

1. 1000 mL NDC - 60577-001-01

2. 250 mL NDC - 60577-001-02

HAND SANITIZER 
silky touch hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60577-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	736.84 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	5 mL  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60577-001-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020	06/24/2020
2	NDC: 60577-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020	06/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2020	06/24/2020

Labeler - VITANE PHARMACEUTICALS, INC. (029029638)

Registrant - VITANE PHARMACEUTICALS, INC. (029029638)

Establishment
Name	Address	ID/FEI	Business Operations
VITANE PHARMACEUTICALS INC		029029638	manufacture(60577-001)

Revised: 6/2020

Document Id: a8d592c5-4acf-93f7-e053-2995a90a6027

34390-5

Set id: a8208c3e-8333-c325-e053-2995a90a8bec

Version: 2

Effective Time: 20200624