LOYAL HAND SANITIZER GEL ALOE VERA- alcohol gel 
LAYAN FOR CHEMICALS EST

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 76% 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 (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol.

Package Label - Principal Display Panel

900 ml label500 ml label500 mL NDC: 76935-100-01

900 mL NDC: 76935-100-02

LOYAL HAND SANITIZER GEL  ALOE VERA
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76935-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL76 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76935-100-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2022
2NDC:76935-100-02900 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2022
Labeler - LAYAN FOR CHEMICALS EST (534691402)
Establishment
NameAddressID/FEIBusiness Operations
LAYAN FOR CHEMICALS EST534691402manufacture(76935-100)

Revised: 12/2021
 
LAYAN FOR CHEMICALS EST