AROMA GUARDIAN- anti bacterial instant hand sanitizer gel 
Opal Cosmetics (Huizhou) Limited

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


Opal, Hand Sanitizer, Gel, 68.5% Ethyl alcohol, 95mL

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic


Antiseptic, Hand Sanitizer


Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.


Flammable. For external use only. Keep away from heat or flame.

Do not use

  • on 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.


  • 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

  • Do not store above 105℉ (40.6℃)
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, t-Butyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Maltodextrin, Denatonium Benzoate.

Package Label - Principal Display Panel


anti bacterial instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42477-2012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.075 mL  in 95 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 27.36 mL  in 95 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.9 mL  in 95 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.285 mL  in 95 mL
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42477-2012-195 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/202004/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/202004/10/2020
Labeler - Opal Cosmetics (Huizhou) Limited (528178475)
Registrant - A03 Lab of BTS (548009541)
NameAddressID/FEIBusiness Operations
Opal Cosmetics (Huizhou) Limited528178475label(42477-2012) , manufacture(42477-2012)

Revised: 10/2021
Opal Cosmetics (Huizhou) Limited