AROMA GUARDIAN- anti bacterial instant hand sanitizer gel

Aroma Guardian by

Drug Labeling and Warnings

Aroma Guardian by is a Otc medication manufactured, distributed, or labeled by Opal Cosmetics (Huizhou) Limited, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• on children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

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

• 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

INGREDIENTS AND APPEARANCE

AROMA GUARDIAN 
anti bacterial instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42477-2016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	178.1 mL  in 260 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	1.04 mL  in 260 mL
WATER (UNII: 059QF0KO0R)	74.88 mL  in 260 mL
GLYCERIN (UNII: PDC6A3C0OX)	5.2 mL  in 260 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)	0.78 mL  in 260 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42477-2016-1	260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/09/2020

Labeler - Opal Cosmetics (Huizhou) Limited (528178475)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Opal Cosmetics (Huizhou) Limited		528178475	label(42477-2016) , manufacture(42477-2016)