FDA Label for Hand Sanitizer Smells Clean

View Indications, Usage & Precautions

Hand Sanitizer Smells Clean Product Label

The following document was submitted to the FDA by the labeler of this product Iwanna Corp Sas. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Hand Sanitizer

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) (70%, 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 (1.00% v/v).
Phenoxyethanol and chlorphenesin (0.3% v/v).
Sterile distilled water or boiled cold water.

Active Ingredient(S)

Alcohol 70% v/v. Purpose: Antiseptic

Phenoxyethanol (and) chlorphenesin: 0.3%

Purpose

Antiseptic, Hand Sanitizer

To help reduce bacteria on the skin that could cause disease.

Indications And Usage

Apply enough hand Sanitizer to cover all hands surface
Rub hands palm to palm
Right palm over left dorsum with interfaced fingers and vice versa.
Palm to palm with fingers interfaced.
Backs of fingers to opposing palms with fingers interlocked.
Rotational rubbing of left thumbs clasped in right palmed and vice versa.
Rotational rubbing backwards and forwards with clasped fingers of right hand and left palm and vice versa.
And your hands are disinfected.

Warnings

Flammable. Keep away from fire or flame

For external use only.

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.

Otc - When Using

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.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

Store between 15-30C (59-86F)
May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, glycerin, Carbomer,DMDM Hydantoin, Triethanolamine

Hand Sanitizer

moisturizes+sanitizes+gel

2.02 FL OZ (60 ML)

NDC:75525-001-07

* Please review the disclaimer below.

Table of Contents

Hand Sanitizer Smells Clean Product Label

Hand Sanitizer

Active Ingredient(S)

Purpose

Indications And Usage

Warnings

Otc - When Using

Otc - Stop Use

Directions

Otc - Keep Out Of Reach Of Children

Other Information

Inactive Ingredients

Package Label - Principal Display Panel

Hand Sanitizer- 500 Ml

Hand Sanitizer 60 Ml

Hand Sanitizer 1000 Ml

Hand Sanitizer 2000 Ml

Hand Sanitizer 120 Ml

Hand Sanitizer 250 Ml

Hand Sanitizer 60 Ml-Dispenser