HYALOLEX HAND SANITIZER WITH LEMON AND ZINC- alcohol solution 
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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Hyalolex Hand Sanitizer with Lemon and Zinc

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial Hand Sanitizer

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 the eyes. In case of contact rinse 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 irritration occurs

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

Directions

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

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Hyalolex Hand Sanitizer with Lemon and Zinc
Safate and Paraben Free
70% Ethyl Alcohol
Antimicrobial
Kills Germs
Package Label - Principal Display Panel

59 mL Label236 mL Label472 mL Label3785 mL Label59 mL NDC: 75540-536-02

236 mL NDC: 75540-536-08

472 mL NDC: 75540-536-16

3785 mL NDC: 75540-536-28

HYALOLEX HAND SANITIZER WITH LEMON AND ZINC 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75540-536
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
ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL) 0.5 mL  in 100 mL
ZINC ALUM (UNII: UGR874142R) 20 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 25 mL  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE) 0.25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75540-536-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
2NDC:75540-536-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
3NDC:75540-536-16472 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
4NDC:75540-536-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/30/2020
Labeler - India Globalization Capital (364601877)

Revised: 12/2021
Document Id: d39e2c27-71d7-8e59-e053-2a95a90a56ba
Set id: a464cf49-2779-9ac3-e053-2995a90ae87e
Version: 3
Effective Time: 20211220
 
India Globalization Capital