Citrus Hand Sanitizing Gel by Elite Health Partners, LLC / Thomas Nyiri / Elite Health Partners

Citrus Hand Sanitizing Gel by

Drug Labeling and Warnings

Citrus Hand Sanitizing Gel by is a Otc medication manufactured, distributed, or labeled by Elite Health Partners, LLC, Thomas Nyiri, Elite Health Partners. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CITRUS HAND SANITIZING GEL- alcohol gel 
Elite Health Partners, LLC

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)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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
  • in 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.

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, Purified Water (USP), Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A, Lauryl Lactate, Fragrance

Package Label - Principal Display Panel

3.78 L NDC: <a href=/NDC/74162-005-01>74162-005-01</a> Source NDC: <a href=/NDC/74971-705>74971-705</a> Healthy Guard Hand Sanitizer 70 Percent Alcohol

NDC: 74162-005-02 30 mL Gaylord Rockies 30 mL Hand Sanitizer Sample Not For Sale NDC: <a href=/NDC/74162-005-02>74162-005-02</a> 30 mL Gaylord Rockies 30 mL Hand Sanitizer Sample Not For Sale

NDC: 74162-005-03 60 mL CIG Hand Sanitizer NDC: <a href=/NDC/74162-005-03>74162-005-03</a> 60 mL CIG Hand Sanitizer

CITRUS HAND SANITIZING GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74162-005(NDC: 74971-705)
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
LAURYL LACTATE (UNII: G5SU0BFK7O)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74162-005-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2020
2NDC: 74162-005-0230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2020
3NDC: 74162-005-0360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202002/26/2021
Labeler - Elite Health Partners, LLC (081156583)
Registrant - Thomas Nyiri (081156583)
Establishment
NameAddressID/FEIBusiness Operations
Elite Health Partners081156583repack(74162-005) , relabel(74162-005)

Revised: 2/2021
Document Id: bc430d66-5a5d-4f37-e053-2a95a90a998f
Set id: adcdfc69-1973-4b3b-e053-2995a90abee2
Version: 5
Effective Time: 20210226