Label: AROMA GUARDIAN- anti bacterial instant hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 42477-2028-1 - Packager: Opal Cosmetics (Huizhou) Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 17, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
AROMA GUARDIAN
anti bacterial instant hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42477-2028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 375 mL in 500 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 2.5 mL in 500 mL WATER (UNII: 059QF0KO0R) 113 mL in 500 mL GLYCERIN (UNII: PDC6A3C0OX) 8 mL in 500 mL TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 1.5 mL in 500 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42477-2028-1 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/17/2020 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(42477-2028) , manufacture(42477-2028)