HYALOLEX HAND SANITIZER WITH LAVENDER AND ZINC- alcohol liquid

Hyalolex Hand Sanitizer with Lavender and Zinc by

Drug Labeling and Warnings

Hyalolex Hand Sanitizer with Lavender and Zinc by is a Otc medication manufactured, distributed, or labeled by India Globalization Capital. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antiseptic, Hand Sanitizer

Use

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

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.

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.

Directions

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

Other information

• Store at 20-25C (68-77F)
• May discolor certain abric

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL

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.

Package Label - Principal Display Panel
Hylolex
Hand Sanitizer
Lavender + Zinc
Sulfate + Paraben Free
70% Ethyl Alcohol
Kills Germs

59 mL NDC: 75540-528-02

HX-HandSanitizer-041020-Lavender2 (1).jpg

INGREDIENTS AND APPEARANCE

HYALOLEX HAND SANITIZER WITH LAVENDER AND ZINC 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75540-528
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
ZINC OXIDE (UNII: SOI2LOH54Z)	100 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	100 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	100 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)	100 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	100 mL  in 100 mL
HEMP (UNII: TD1MUT01Q7)	100 mL  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	100 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75540-528-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/20/2020

Labeler - India Globalization Capital, Inc. (364601877)