HYALOLEX HAND SANITIZER WITH LAVENDER AND ZINC- alcohol liquid 
India 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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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

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

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 Label59 mL NDC: 75540-528-02

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

HYALOLEX HAND SANITIZER WITH LAVENDER AND ZINC 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75540-528
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HEMP (UNII: TD1MUT01Q7) 100 mL  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE) 100 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 100 mL  in 100 mL
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75540-528-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/20/2020
Labeler - India Globalization Capital (364601877)

Revised: 1/2023
Document Id: f1a01bba-46bc-af4e-e053-2a95a90a0f67
Set id: a361357b-73bf-e674-e053-2995a90ab464
Version: 7
Effective Time: 20230106
 
India Globalization Capital