Label: HAND SANITIZER - FOUR THIEVES BLEND- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74322-002-01, 74322-002-02, 74322-002-03 - Packager: Mount Royal Soaps, LLC
- 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 3, 2020
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- Product Decription & Introduction
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER - FOUR THIEVES BLEND
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74322-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 63 mL in 100 mL Inactive Ingredients Ingredient Name Strength LEMON OIL (UNII: I9GRO824LL) 0.19 mL in 100 mL ROSEMARY OIL (UNII: 8LGU7VM393) 0.13 mL in 100 mL TEA TREE OIL (UNII: VIF565UC2G) 0.13 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL in 100 mL CLOVE OIL (UNII: 578389D6D0) 0.08 mL in 100 mL EUCALYPTUS OIL (UNII: 2R04ONI662) 0.11 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.4 mL in 100 mL WATER (UNII: 059QF0KO0R) 34 mL in 100 mL CINNAMON LEAF OIL (UNII: S92U8SQ71V) 0.06 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74322-002-01 59.1471 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/03/2020 2 NDC:74322-002-02 118.294 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/03/2020 3 NDC:74322-002-03 3785.41 mL in 1 JUG; Type 0: Not a Combination Product 04/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/03/2020 Labeler - Mount Royal Soaps, LLC (081382906) Registrant - Mount Royal Soaps, LLC (081382906) Establishment Name Address ID/FEI Business Operations Charm City Meadworks 051441049 manufacture(74322-002) , pack(74322-002) , label(74322-002) Establishment Name Address ID/FEI Business Operations Mount Royal Soaps, LLC 081382906 manufacture(74322-002) , pack(74322-002) , label(74322-002)
