Sterlomax E-80 Naturals Hand Sanitizer Gel 59ml

Sterlomax Hand Sanitizer by

Drug Labeling and Warnings

Sterlomax Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Natures Only Inc., VB MEDICARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STERLOMAX HAND SANITIZER- alcohol gel 
Natures Only Inc.

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Sterlomax E-80 Naturals Hand Sanitizer Gel 59ml

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.

Active Ingredient(s)

Alcohol 80% 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

Glycerin, Ocimum Tenuliforum Leaf Extract, Citric Acid, Aloe Leaf, Purified water USP, Carbomer, Aminomethyl propanol, Tocopheryl Acetate, Propylene glycol, Polyethylene Glycol, Isoprpyle Myristate, Fragrance

Package Label - Principal Display Panel

59 mL NDC: 79561-012-01

STERLOMAX HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79561-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	47.2 mL  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.86 mL  in 59 mL
WATER (UNII: 059QF0KO0R)	9.4 mL  in 59 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.18 mL  in 59 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.012 mL  in 59 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.12 mL  in 59 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.15 mL  in 59 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.04 mL  in 59 mL
OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)	0.12 mL  in 59 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.885 mL  in 59 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79561-012-01	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/20/2020	03/31/2024

Labeler - Natures Only Inc. (117570740)

Registrant - Natures Only Inc. (117570740)

Establishment
Name	Address	ID/FEI	Business Operations
VB MEDICARE PRIVATE LIMITED		650317659	manufacture(79561-012)

Revised: 9/2024

Document Id: 21ef4832-9604-90f2-e063-6294a90a1f76

34390-5

Set id: ab153810-13b2-16e6-e053-2a95a90a440a

Version: 6

Effective Time: 20240912