Gilway Antiseptic Hand Saniizer 3.8L by Nu-World Corporation

Gilway Antiseptic Hand Saniizer 3.8L by

Drug Labeling and Warnings

Gilway Antiseptic Hand Saniizer 3.8L by is a Otc medication manufactured, distributed, or labeled by Nu-World Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GILWAY ANTISEPTIC HAND SANIIZER 8 FL.OZ- alcohol gel 
STAYCLEAN MOISTURIZING HAND GEL SANITIZER 3.8L- alcohol gel 
GILWAY ANTISEPTIC HAND SANIIZER 3.8L- alcohol gel 
Nu-World Corporation

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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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 72% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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
  • on 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.

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

Water, Carbomer, Aminomethyl Propanol,Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Ethyl Hexanediol, Phenoxyethanol

Package Label - Principal Display Panel

Packaging Label3.8L NDC: 68577-013-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging Label3.8L NDC: 68577-014-00

Package Label. Principal Display-8 fl.oz

Packaging Label- 8 fl.oz8 fl.oz(236 ml) , NDC# 68577-021

GILWAY ANTISEPTIC HAND SANIIZER 8 FL.OZ 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68577-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.65597 mL  in 100 mL
ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68577-021-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/202012/31/2022
STAYCLEAN MOISTURIZING HAND GEL SANITIZER 3.8L 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68577-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.65597 mL  in 100 mL
ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68577-014-003800 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/19/202012/31/2022
GILWAY ANTISEPTIC HAND SANIIZER 3.8L 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68577-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.65597 mL  in 100 mL
ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68577-013-003800 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/202012/31/2022
Labeler - Nu-World Corporation (628045858)
Registrant - Nu-World Corporation (628045858)
Establishment
NameAddressID/FEIBusiness Operations
Nu-World Corporation628045858manufacture(68577-013, 68577-014, 68577-021)

Revised: 1/2023
Document Id: f28c8bb9-9714-7f2f-e053-2a95a90a6430
Set id: a6cb12d2-8e86-62f0-e053-2995a90ad032
Version: 3
Effective Time: 20230118
 
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