HAND SANITIZER SMELLS CLEAN- ethanol gel 
IWANNA CORP SAS

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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HAND SANITIZER

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 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.

Directions

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

Other information

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

HS Label 500 ML

HAND SANITIZER 60 ML

Hand Sanitizer

moisturizes+sanitizes+gel

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

HS LABEL 60 ML

HAND SANITIZER 1000 ML

Hand Sanitizer

moisturizes+sanitizes+gel

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

HS LABEL 1000 ML

HAND SANITIZER 2000 ML

Hand Sanitizer

moisturizes+sanitizes+gel

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

HS LABEL 2000 ML

HAND SANITIZER 120 ML

Hand Sanitizer

moisturizes+sanitizes+gel

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

HS LABEL 120 ML

HAND SANITIZER 250 ML

Hand Sanitizer

moisturizes+sanitizes+gel

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

HS LABEL 250 ML

HAND SANITIZER 60 ML-DISPENSER

Hand Sanitizer

moisturizes+sanitizes+gel

2.02 FL OZ (60 ML)

NDC:75525-001-07

HS LABEL 60ML DISP

HAND SANITIZER 2000 ML DISP

Hand Sanitizer

moisturizes+sanitizes+gel

67.6 fl. oz (2000 mL) NDC: 75525-001-21

HS LABEL 2000 ML DISP

HAND SANITIZER 3875 ML DISP

Hand Sanitizer

moisturizes+sanitizes+gel

131 fl. oz (3875 mL) NDC: 75525-001-40

HS LABEL 3875 ML

HAND SANITIZER 1000 ML DISP

Hand Sanitizer

moisturizes+sanitizes+gel

33.8 fl. oz (1000 mL) NDC: 75525-001-11

HS LABEL 1000 ML DISP

HAND SANITIZER 500 ML DISP

Hand Sanitizer

moisturizes+sanitizes+gel

16.9 fl. oz (500 mL) NDC: 75525-001-51

HS LABEL 500 ML DISP

HAND SANITIZER SMELLS CLEAN 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75525-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ) CHLORPHENESIN0.143 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.143 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
TROLAMINE (UNII: 9O3K93S3TK) 0.479 g  in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW) 0.095 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75525-001-0660 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
2NDC:75525-001-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
3NDC:75525-001-101000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
4NDC:75525-001-202000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
5NDC:75525-001-25250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
6NDC:75525-001-12120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
7NDC:75525-001-0760 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
8NDC:75525-001-51500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
9NDC:75525-001-111000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
10NDC:75525-001-212000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
11NDC:75525-001-403875 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - IWANNA CORP SAS (883223177)
Registrant - MASTER CUSTOMS BROKER (054631555)
Establishment
NameAddressID/FEIBusiness Operations
IWANNA CORP SAS883223177manufacture(75525-001)

Revised: 12/2020
Document Id: b5854bc8-de41-0594-e053-2995a90a1417
Set id: a2ab8a62-4030-4eb2-e053-2995a90a91d2
Version: 5
Effective Time: 20201202
 
IWANNA CORP SAS