HAND SANITIZER SMELLS CLEAN- ethanol gel

Hand Sanitizer Smells Clean by

Drug Labeling and Warnings

Hand Sanitizer Smells Clean by is a Otc medication manufactured, distributed, or labeled by IWANNA CORP SAS, MASTER CUSTOMS BROKER. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

1. 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.
2. Glycerol (1.00% v/v).
3. Phenoxyethanol and chlorphenesin (0.3% v/v).
4. 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.

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.

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.

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

Package Label - Principal Display Panel

Hand Sanitizer

moisturizes+sanitizes+gel

Hand Sanitizer- 500 ML

Hand Sanitizer

moisturizes+sanitizes+gel

16.9 fl. oz (500 mL) NDC: 75525-001-50

HAND SANITIZER 60 ML

Hand Sanitizer

moisturizes+sanitizes+gel

2.02 fl. oz (60 mL) NDC: 75525-001-06

HAND SANITIZER 1000 ML

Hand Sanitizer

moisturizes+sanitizes+gel

33.8 fl. oz (1000 mL) NDC: 75525-001-10

HAND SANITIZER 2000 ML

Hand Sanitizer

moisturizes+sanitizes+gel

67.6 fl. oz (2000 mL) NDC: 75525-001-20

HAND SANITIZER 120 ML

Hand Sanitizer

moisturizes+sanitizes+gel

4.0 fl. oz (120 mL) NDC: 75525-001-12

HAND SANITIZER 250 ML

Hand Sanitizer

moisturizes+sanitizes+gel

8.4 fl. oz (250 mL) NDC: 75525-001-25

INGREDIENTS AND APPEARANCE

HAND SANITIZER SMELLS CLEAN 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75525-001
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
CHLORPHENESIN (UNII: I670DAL4SZ)	0.143 g  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.2685 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.95 g  in 100 mL
WATER (UNII: 059QF0KO0R)	27.8 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.009 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.143 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.479 g  in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.095 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75525-001-06	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75525-001-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
3	NDC: 75525-001-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC: 75525-001-20	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
5	NDC: 75525-001-25	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
6	NDC: 75525-001-12	120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - IWANNA CORP SAS (883223177)

Registrant - MASTER CUSTOMS BROKER (054631555)

Establishment
Name	Address	ID/FEI	Business Operations
IWANNA CORP SAS		883223177	manufacture(75525-001)