Hyalolex Hand Sanitizer Lavender Vitamin E + Aloe Vera Sulfate + Paraben Free 70% Ethyl Alcohol Antimicrobial

Hyalolex Hand Sanitizer Lavender by

Drug Labeling and Warnings

Hyalolex Hand Sanitizer Lavender by is a Otc medication manufactured, distributed, or labeled by Enter Labeler NameIndia Globalization Capital. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYALOLEX HAND SANITIZER LAVENDER- alcohol liquid 
Enter Labeler NameIndia Globalization Capital

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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Hyalolex Hand Sanitizer Lavender
Vitamin E + Aloe Vera
Sulfate + Paraben Free
70% Ethyl Alcohol
Antimicrobial

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 70% v/v. Purpose: Antiseptic, antimicrobial

Purpose

Antiseptic, Hand Sanitizer, antimicrobial

Use

Hand Sanitizer to help reduce germs on the skin.

Warnings

For external use only. Flammable. Keep away from fire or flame

Do not use

in or near eyes. Incase of contact, rinse eyes thoroughly with water.

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 if irritation appears.

Keep out of reach of children.

Directions

• Wet handswith product and briskly rub hands together until dry.
• Supervise children under 6 years in use of this product.

Other information

• Store between 20-25C (68-77F)
• May discolor certain fabrics

Inactive ingredients

Purified water USP, Acrylate Copolymer, Glycerin, Carbomer, Propylene Glycol, Aloe Leaf Extract, Lavender Oil, Hydroxypropyl Methylcellulose, Fragrance, tocopheryl Acetate

75540-583-04

Package Label - Principal Display Panel

59 mL NDC: 75540-583-02

HYALOLEX HAND SANITIZER LAVENDER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75540-583
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
PROPYLENE GLYCOL 1-STEARATE (UNII: 32I3MRN561)	1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.05 mL  in 100 mL
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)	1 mL  in 100 mL
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)	1 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)	0.8 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20.29 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75540-583-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/30/2023
2	NDC: 75540-583-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/30/2023
3	NDC: 75540-583-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/30/2023
4	NDC: 75540-583-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	04/30/2023

Labeler - Enter Labeler NameIndia Globalization Capital (364601877)

Revised: 2/2023

Document Id: f45e4f1d-f65d-d87e-e053-2a95a90a7fbb

34390-5

Set id: b4a716f6-76f7-f4a7-e053-2995a90a0e48

Version: 3

Effective Time: 20230210

 

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