NDC 42477-2023

Aroma Guardian

Anti Bacterial Instant Hand Sanitizer

Aroma Guardian is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Opal Cosmetics (huizhou) Limited. The primary component is Alcohol.

• Product ID: 42477-2023_a36e4fb3-17b7-2ea4-e053-2a95a90ab7fe
• NDC: 42477-2023
• Product Type: Human Otc Drug
• Proprietary Name: Aroma Guardian
• Generic Name: Anti Bacterial Instant Hand Sanitizer
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-04-17
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333E
• Labeler Name: Opal Cosmetics (Huizhou) Limited
• Substance Name: ALCOHOL
• Active Ingredient Strength: 74 mL/98mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 42477-2023-1

98 mL in 1 TUBE (42477-2023-1)

• Marketing Start Date: 2020-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42477-2023-1 [42477202301]

Aroma Guardian GEL

• Marketing Category: OTC monograph not final
• Application Number: part333E
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-17

Drug Details

Active Ingredients

Ingredient	Strength
ALCOHOL	73.5 mL/98mL

OpenFDA Data

• SPL SET ID: a36e4fb3-17b6-2ea4-e053-2a95a90ab7fe
• Manufacturer:
  • Opal Cosmetics (Huizhou) Limited
• UNII:
  • 3K9958V90M

NDC Crossover Matching brand name "Aroma Guardian" or generic name "Anti Bacterial Instant Hand Sanitizer"

NDC	Brand Name	Generic Name
42477-2012	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer
42477-2013	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer
42477-2016	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer
42477-2018	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer
42477-2022	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer
42477-2023	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer
42477-2026	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer
42477-2028	Aroma Guardian	Anti Bacterial Instant Hand Sanitizer