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

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.

----------

Opal, Hand Sanitizer, Gel, 75% Ethyl alcohol, 95mL

Active Ingredient(s)

Ethyl Alcohol 75% 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

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

Do not use

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

Other information

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

95

AROMA GUARDIAN 
anti bacterial instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42477-2022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71.25 mL  in 95 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.475 mL  in 95 mL
WATER (UNII: 059QF0KO0R) 21.47 mL  in 95 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.52 mL  in 95 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.285 mL  in 95 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42477-2022-195 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/17/2020
Labeler - Opal Cosmetics (Huizhou) Limited (528178475)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Opal Cosmetics (Huizhou) Limited528178475label(42477-2022) , manufacture(42477-2022)

Revised: 4/2020
Document Id: a36e15e6-8ca1-ffc4-e053-2995a90aecf0
Set id: a36e15e6-8ca0-ffc4-e053-2995a90aecf0
Version: 1
Effective Time: 20200417
 
Opal Cosmetics (Huizhou) Limited